Escolar Documentos
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Key Abstracts
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Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P6.10, 3-5 April 2005 Clinical experiences with icodextrin 4% solution in open and laparoscopic general surgery in the multicentre ARIEL registry Ommer A, Walz MK on behalf of the ARIEL registry group. Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O34, 16-18 September 2004 Ease of use and safety of icodextrin 4% solution in the prevention of adhesions after general surgery: experience from the multicentre ARIEL registry Menzies D, Hidalgo M, Walz M K, Duron JJ, Tonelli F. Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, P31, 16-18 September 2004 A pilot study of adjuvant intraperitoneal 5-fluorouracil using 4% icodextrin as a novel carrier solution Hosie KB, Kerr DA, Gilbert JA, Downes M, Lakin G, Pemberton G et al. Published in: European Journal of Surgical Oncology 2003;29:254-260 Use of anti-adhesion agents in colorectal surgery focus on infection and anastomosis Parker M on behalf of the ARIEL Registry contributors. Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Late Breaking Abstracts 1 Colorectal cancer adhesions and chemotherapy Wilson M. Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003: Late Breaking Abstracts 3 13 11 10 9 8
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Sutton C, Menzies DM, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F, Prieto C, Pascual H. Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews In Gynaecological Practice June ; 3 (1): O03 European experience with icodextrin 4% solution in routine surgical practice Menzies D, Parker MC, Sutton C, Duron JJ, Walz MK, Tonelli F, Pascual H, Pouly JL, Korell M, Minelli L, Prieto C. Presented at: European Council Of Coloproctology, 9th Biennial Congress, Athens, May 31-June 4 2003 Abdominal drains do not affect antiadherential efficacy of 4% icodextrin:Experimental Study Infantino A, Bruno C, Roberto G. Presented at: European Council of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003 European experience with icodextrin 4% solution in routine surgical practice Menzies DM, Sutton C, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F, Prieto C, Pascqal H. Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium III Abstract III(9) Demonstrating the clinical and cost effectiveness of adhesion reduction strategies Wilson MS, Menzies D, Knight AD, Crowe AM. Published in: Colorectal Disease 2002; 4: 355-360 22 20 18 16
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SCAR-3: Comparative risks of colorectal procedures Wilson MS on behalf of the SCAR group. Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract SCAR 2 - The risk of adhesions following colorectal surgery Sunderland G on behalf of the SCAR panel.
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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Published in: Late Breaking Abstracts 2 Adhesion-related readmissions following gynaecological laparoscopy or gynaecological laparotomy in Scotland. An epidemiological study of 24,046 patients Lower AM, Hawthorn RJS, Clark D, Knight AD, Crowe AM on behalf of the SCAR panel. Presented at: 19th European Society of Human Reproduction and Embryology Annual Meeting: xviii53 O-156 29th June - 2nd July 2003. Published in: Human Reprod 2003; 18 (suppl 1): 53 Adhesion-related readmissions following gynaecological laparoscopy in Scotland. An epidemiological study of 24,046 patients Hawthorn RJS, Lower A, Clark D, Knight AD, Crowe AM, on behalf of the SCAR panel. Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews in Gynaecological Practice, June 2003; 3 (1): 01 Adhesion related readmissions following colorectal surgery in Scotland. An epidemiological study of 4,912 patients Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM. Presented at: European Council Of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003 Adhesion-related readmission rates in Scotland between 1996 and 2000 Wilson M, Parker M, Menzies D, Lower A, Hawthorn R, Thompson J et al. Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium VII Abstract VII(6) 43 41 39 37
The burden of adhesions - evaluating the clinical impact and the value of adhesion reduction strategies Wilson MS, Menzies D, Knight AD, Crowe AM. Presented at: European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 3-6 The impact of adhesions following colorectal surgery today evaluating the potential impact tomorrow Parker MC, Wilson MS, Menzies D, Clark D, Ford I, Knight AD. Presented at : European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 7-10 Adhesion related outcomes in 9,599 patients undergoing colon surgery between 1996-98 Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM.
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Presented at: The Association of Coloproctology of Great Britain and Ireland Annual Meeting, Manchester, June 2002
Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P6.10, 3-5 April 2005
Ease of use of icodextrin 4% solution in the reduction of adhesions following gynaecological surgery in Belgium
Foidart JM, Nisolle M. OBJECTIVE: To monitor ease of use and patient acceptability of icodextrin 4% solution (Adept) in routine gynecological surgery in Belgium. DESIGN AND METHODS: With the introduction of 4% icodextrin solution, the Belgium Adept Registry (BAR) was established. Gynaecologists from 22 centres evaluated its ease of use and patient acceptability in routine gynaecological surgery associated with a risk of adhesions. Anonymised data collection forms were submitted to the BAR central database. RESULTS: Routine use of icodextrin 4% solution was assessed in 199 patients (n=148 laparoscopies, n=51 laparotomies). The median volume of icodextrin 4% solution used for irrigation and instillation was 500 mL and 1000 mL respectively for both laparoscopies and laparotomies. Most surgeons rated the ease of use (viewing of surgical field, handling of tissues) of icodextrin 4% solution as excellent or good and fluid leakage from surgical sites as normal (63% of laparoscopies and 65% of laparotomies) or less than normal (19% of laparoscopies, 14% of laparotomies). Abdominal discomfort was rated as expected in 63% of laparoscopies and 73% of laparotomies, and less than expected in 29% of laparoscopies and 20% of laparotomies. Abdominal distension figures were comparable. CONCLUSIONS: Feedback from BAR indicates that icodextrin 4% solution used as an irrigant and post-operative instillate was very well tolerated by patients and contributing gynaecologists found it easy to use in surgery for the reduction of adhesions. Although side effects have not been systematically recorded in BAR, Adept overall tolerance was judged to be excellent as was substantiated by the larger pan European ARIEL registry which assessed safety in 4620 patients.
Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O34, 16-18 September 2004
Clinical experiences with icodextrin 4% solution in open and laparoscopic general surgery in the multicentre ARIEL registry
Ommer A, Walz MK on behalf of the ARIEL registry group. INTRODUCTION: Major abdominopelvic surgery is associated with a substantial risk and burden of adhesions. The Adept Registry for Clinical Evaluation (ARIEL) was established to evaluate the acceptability of icodextrin 4% solution (Adept) an intraoperative device approved in Europe to reduce post-surgical adhesion formation in routine surgery. PATIENTS AND METHODS: Participating surgeons assessed 1738 patients undergoing open (1469) or laparoscopic (269) general surgery (45.8% included adhesiolysis) in 103 surgical centres in 5 European countries. Ease of use, acceptability and safety of icodextrin were evaluated. RESULTS: Mean volumes of icodextrin used in open surgery were 871 ml (irrigant) and 999 ml (instillate), in line with the manufacturers recommendations (irrigant, 100ml every 30 minutes; instillate 1L). Ease of use was described as okay, good or excellent in most cases (96%). Abdominal discomfort/distension were reported to be less than or as expected in most patients (discomfort, 91%; distension, 90%). Drains were used in 698 patients (47.5%; France 42%, Germany 75%, Italy, 96%, Spain 57%, UK 37%) and most surgeons (63%) reported drain loss to be 'as expected' (mean SD; 279 312 ml). Peritonitis or intra-abdominal infections/abscess occurred in 0.27% of patients. The incidence of anastomotic leakage, in 983 open anastomotic procedures, was 2.7%. In the largest group (colorectal procedures, 761) incidences of anastomotic leakage were: right colon, 4.5%; rectum, 4.3%; unspecified 3.3%; left colon, 0%. CONCLUSION: Icodextrin 4% solution is easy to use and can be used with drains. In ARIEL, post-operative complication rates were minimal and were in line with rates published in the general surgery literature.
Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, P31, 16-18 September 2004
Ease of use and safety of icodextrin 4% solution in the prevention of adhesions after general surgery: experience from the multicentre ARIEL registry
Menzies D, Hidalgo M, Walz M K, Duron JJ, Tonelli F. AIM: The likelihood of developing adhesions following abdominolpelvic surgery is substantial. The Adept Registry for Clinical Evaluation (ARIEL) investigated the acceptability of icodextrin 4% solution (Adept) an intra-operative device approved in Europe to reduce post-surgical adhesion formation METHOD: Surgeons from 103 European centres evaluated icodextrin for ease of use, acceptability and adverse events in 1738 patients (UK 902, Spain 440, Germany 167, France 141, Italy 88) undergoing open (1469) or laparoscopic (269) general surgery (45.8% included adhesiolysis). RESULTS: For open surgery, mean volumes of icodextrin used were 871 ml for irrigation and 999 ml for instillation. Ease of use was described as okay, good or excellent in 96% of cases. In procedures using drains (47.5%), most surgeons (63%) reported drain loss to be as expected (mean SD; 279 312 ml). Incidence of peritonitis or intra-abdominal infections/abscess in open surgery was 0.27%, postoperative ileus 3.6% and healing or infection of wound sites, 3.8%. In 983 open anastomotic procedures, 27 leaks (2.7%) were reported. Laparoscopic data will also be presented. CONCLUSION: Icodextrin 4% solution was easy to use and can be used with drains. Post-operative complication rates were in line with published literature on complications in general surgery.
A pilot study of adjuvant intraperitoneal 5-flouracil using 4% icodextrin as a novel carrier solution
Hosie KB, Kerr DA, Gilbert JA, Downes M, Lakin G, Pemberton G et al. AIM: This pilot study utilised the sustained intraperitoneal (i.p.) dwell properties of an iso-osmotic solution of 4% icodextrin to investigate the tolerability, toxicity and feasibility of home-based i.p. 5FU adjuvant chemotherapy following resective surgery for colorectal cancer. METHODS: Twenty eligible patients (Dukes' stage B and C with potentially curative resection) underwent perioperative Tenckhoff catheter placement. Ten (6 male, 4 female, aged 46-85; mean 67.5 years) received 5FU chemotherapy. After initial flushing and gradual increase in volumes of 4% icodextrin alone, patients received home-based i.p. 5FU (150-300 mg/m(2)/day given as equal doses at 12-hourly intervals) for 14 days, with a 14-day recovery period, for a maximum of 6 courses. Two incurable patients, treated on compassionate grounds, provided further safety data. RESULTS: Nine of the 10 patients became proficient in self-treatment with 5FU and two completed 6 courses. Frequent abdominal pain was the main dose-limiting toxicity of 5FU, causing withdrawal of three patients after a high (300 mg/m(2)/day) first course and one following a third course at lower doses. I.p. 5FU concentrations (mean>30000 ngml(-1)) were 1000 fold higher than systemic venous levels. Bacterial peritonitis led to two withdrawals but was not a frequent event (microbiologically confirmed incidence of 1 per 27 catheter-months). CONCLUSIONS: Home-based i.p. adjuvant chemotherapy is a feasible treatment option in patients with surgically resected colorectal carcinoma.
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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Late Breaking Abstracts 1
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solution or surgery alone4. Initial analysis of ARIEL Registry feedback on patients undergoing open surgery where an anastomosis was formed, indicates a leak rate of 2.9% which is close to the 46% rates most frequently reported in a recent systematic review of anastomotic leaks after gastrointestinal surgery5. This and other safety aspects of the use of Adept are being rigorously monitored. Reported adverse incidents from ARIEL Registry contributors (solicited reports) and spontaneous reporting are reassuringly low and consistent with those expected for a peritoneal instillate. References:
1. Parker MC, Ellis H, Moran BJ et al. Postoperative adhesions: Ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum 2001; 44: 82230. 2. Coleman MG, McLain AD, Moran BJ. Impact of previous surgery on time taken for incision and division of adhesions during laparotomy. Dis Colon Rectum 2000; 43: 12979. 3. Van der Krabben AA, Dijkstra FR, Nieuwenhuijzen M et al. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg 2000; 87: 46771. 4. Rodgers KE, Verco SJS, diZerega GS. Effects of intraperitoneal 4% icodextrin solution on the healing of bowel anastomoses and laparotomy incisions in rabbits. Colorectal Dis 2003; 5: 32430. 5. Bruce J, Krokowski ZH, Al-Khairy G et al. Systematic review of the definition and measurement of anastamotic leak after gastrointestinal surgery. Br J Surg 2001; 88: 115768.
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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003: Late Breaking Abstracts 3
The challenge is first to confirm that this type of therapy is feasible and then to go on to perform prospective randomised studies to see if this approach is the next weapon to use in the battle against colorectal cancer.
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Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews In Gynaecological Practice June ; 3 (1): O03
Presented at: European Council Of Coloproctology, 9th Biennial Congress, Athens, May 31-June 4 2003
abdominal discomfort associated with a post operative instillate this was scored as what would be normally expected or less than expected by 84.4% - only 1.9% reported some clinical concern. ARIEL data is received regularly and updated monthly, latest data will be presented. CONCLUSIONS: The ARIEL Registry will provide the largest body of experience of an adhesion reduction agent in routine surgery, providing vital information on the acceptability of 4% icodextrin solution to surgeons and patients. It also provides an optimal Pharmacovigilance tool to monitor potential complications. Initial data suggests Adept is very well received by surgeons and patients as part of routine surgery.
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Presented at: European Council of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003
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RESULTS: Total score per group was: 5 for Group 1; 7 for Group 2; 2 for Group 3 and 13 for Group 4. Loss of liquid through the drains was 19.2% of instilled icodextrin in Group 1, and 15% in Group 2. Our pilot study shows that icodextrin, 15 days after surgery, is efficacious in preventing peritoneal adhesions and reducing adhesions severity. Even though a reduced number of adhesions was observed in those animals with no drains (Group 3) compared to animals with drains (Group 1 and 2), the occurrence of adhesions seems little related to the mild liquid loss, considering the volume (50 ml) introduced during surgery. CONCLUSIONS: We conclude that 4% icodextrin is able to prevent adhesions, even when used in the presence of drains, perhaps with an effect proportional to time of contact with the peritoneum.
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Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 1012 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium III Abstract III(9)
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Patient abdominal discomfort Excessive 1.1% 0.7% 2.7% <Normal <Normal 0.0% 5.6% 5.9%
Excellent
2.2%
0.0%
50.0% 36.3%
7.4%
0.0%
0.0%
0.0%
0.0%
CONCLUSIONS: The ARIEL Registry will provide the largest body of experience of an adhesion-reduction agent in routine surgery, providing vital information on the acceptability of 4% icodextrin solution to surgeons and to patients. It also provides an optimal pharmacovigilance tool to monitor potential complications.
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Normal
Good
Poor
Bad
OK
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Effects of intraperitoneal 4% icodextrin solution on the healing of bowel anastomosis and laparotomy incisions in rabbits
Rodgers KE, Verco SJS, diZerega GS. OBJECTIVE: Peri-operative lavage and postoperative instillation of a 4% icodextrin solution reduces de novo formation and reformation of peritoneal adhesions following abdominal surgery. This experimental study evaluated the effects of 4% icodextrin treatment on the healing of bowel anastomoses and laparotomy incisions. MATERIALS AND METHODS: Female New Zealand White rabbits (weight 2.21-2.77 kg) were randomised by ascending weight to one of 3 surgical treatments, each with 2 termination points (6 groups of 8 animals). The treatments were anastomotic bowel surgery alone or with lavage and postoperative instillation of either 4% icodextrin solution or Lactated Ringer's Solution (LRS). The solutions were coded A and B by the supplier, so that the study personnel were blinded to their identity. After the abdomen was opened, 30 ml of solution A or B was instilled and removed by aspiration prior to surgery. The ascending colon was then transected 5 cm aboral to the ileocaecal junction and the ends anastomosed. During surgery, 5 ml of the solution was applied 4 times at the surgical site, and a further 30 ml was administered and aspirated as a postoperative lavage. Just prior to closure of the abdominal wall, 50 ml of the solution was administered as a postoperative instillate. Duplicate treatment groups were terminated 7 and 21 days after surgery and the anastomotic sites inspected for adhesion and/or abscess formation. In 6 animals per group, an 8-12 cm length of colon including the anastomotic site was removed for measurement of bursting pressure, and a section of the abdominal wall including the incision line was tested for breaking strength. The other 2 animals per group provided tissue for histological analysis of wound healing at the bowel and incision sites. RESULTS: There was no significant difference between the 3 treatment groups for any parameter (P > 0.05). Compared with the surgical control at either day 7 or 21 after surgery, the administration of solutions A or B did not affect the formation of abscesses or adhesions, the bursting strength of the bowel, or the tear strength of the abdominal wall incision. Histological assessment of the quality of wound healing showed no differences between treatment groups in inflammatory cell infiltration, fibroblast density, blood vessel formation or collagen maturity.
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CONCLUSIONS: The use of a 4% icodextrin solution for peri-operative lavage and postoperative instillation in a rabbit model of bowel anastomotic healing did not result in any difference from either LRS treated or untreated surgical controls.
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The SCAR-3 study: 5-year adhesion-related readmission risk following lower abdominal surgical procedures
Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD and Crowe AM on behalf of the Surgical and Clinical Adhesions Research (SCAR) Group. OBJECTIVE: The Surgical and Clinical Adhesions Research (SCAR) and SCAR-2 studies demonstrated that the burden of adhesions following lower abdominal surgery is considerable and appears to remain unchanged despite advances in strategies to prevent adhesions. In this study, we assessed the adhesion-related readmission risk directly associated with common lower abdominal surgical procedures, taking into account the effect of previous surgery, demography and concomitant disease. METHODS: Data from the Scottish National Health Service medical record linkage database were used to assess the risk of an adhesion-related readmission following open lower abdominal surgery during April 1996-March 1997. RESULTS: Patients undergoing lower abdominal surgery (excluding appendicectomy) had a 5% risk of readmission directly related to adhesions in the 5 years following surgery. Appendicectomy was associated with a lower rate of readmission (0.9%), but contributed over 7% of the total lower abdominal surgery patient readmission burden. Panproctocolectomy (15.4%), total colectomy (8.8%) and ileostomy surgery (10.6%) were associated with the highest risk of an adhesion-related readmission. Overall, the risk of readmission was doubled in patients who had undergone abdominal or pelvic surgery within 5 years of the incident operation. A higher risk of readmission was also recorded in patients aged < 60 years compared with those aged >60 years. The effect of gender was assessed. However, as the surgical codes used were found to be skewed towards women, these data have not been reported. Readmission risk was slightly higher in patients with concomitant peritonitis compared with patients without peritonitis. In contrast, Crohn's disease had no effect on risk. Patients with colorectal cancer had a lower risk of adhesion formation. However, this may have been due to the type of surgery performed in this patient group. CONCLUSION: The identification of high-risk patient subgroups may assist in effectively targeting adhesion-prevention strategies and the proffering of preoperative advice on adhesion risk.
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Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P4.01, 3-5 April 2005
SCAR-3: what factors affect adhesion-related readmission risk following gynaecological surgery?
Lower AM, Hawthorn R. OBJECTIVES: To determine adhesion-related readmission risk during 5 years following laparoscopic gynaecological surgery and to assess the influence of previous abdominopelvic surgery, surgery type, and concomitant disease, on risk. DESIGN AND METHODS: This epidemiological study used data from the Scottish National Health Service medical record linkage database to determine an incident cohort of patients undergoing laparoscopic surgery during 1996-1997. These patients were followed up for adhesion related readmissions over a 5-year period. Readmissions were identified using surgical codes selected from the Office of Population Censuses and Surveys, Fourth Edition (OPSC4) and diagnostic codes from the International Code of Diseases, Tenth Edition (ICD10). RESULTS: A total of 6,276 laparoscopic procedures (excluding sterilisations) were conducted in Scotland during 1996-1997 and 33% of patients had undergone surgery within the previous 5 years. Diagnoses at the time of surgery included endometriosis (18%), inflammatory disease of the female genitalia (12%) and pain (33%). The overall risk of a direct adhesion-related readmission within 5 years was 2.5%. This increased to 3.5% in patients that had previously undergone abdominopelvic surgery. Concomitant endometriosis and inflammatory disease did not increase readmission risk. However, ahesiolysis, which occurred in 4% of procedures, was associated with the highest risk of readmission; patients who had previously undergone surgery and subsequently underwent adhesiolysis had a risk of readmission of 6.8%. CONCLUSIONS: This study indicates that adhesiolysis procedures and previous abdominopelvic surgery are associated with an increased risk of adhesions following laparoscopic gynaecological surgery.
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Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O35, 16-18 September 2004
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Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9 July 2004
A review of key consent risk information provided for gynaecological procedures revealed the following; a less than 1 in 1003 risk of a serious complication due to general anaesthesia and an estimated 1 in 1000 risk of pain, bleeding, infection or damage to the bowel or bladder in sterilisation procedures. These risks are all lower than the reported risk of readmission for conditions directly related to adhesions in the year following surgery. Our research indicates that few consent forms mention adhesion complications and none include an estimate of the associated risk. Adhesion-related readmissions are a serious complication of gynaecological surgery which can lead to infertility and in the most serious cases small bowel obstruction and death. Informing patients of these risks would seem appropriate based on comparisons to other surgical risk data currently provided.
References: 1. Lower AM, Hawthorn RJS, Ellis H et al. The impact of adhesions on hospital readmissions over ten years after 8489 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. Br J Obstet Gynaecol 2000; 107: 855-862. 2. Lower AM, Hawthorn RJS, Clark D et al. Adhesion-related readmissions following gynaecological laparoscopy or laparotomy in Scotland. An epidemiological study of 24,046 patients. Human Reprod 2004; 19(8): 1877-85. 3. Addenbrookes NHS Trust, Gynaecological Services. Patient agreement to investigation of treatment: Laparoscopic sterilisation.
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Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract
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Surgical category Directly related All patients (n=12756) Colon (n=3176) Total colectomies/ileostomies - with peritonitis - with colorectal cancer Right hemicolectomies (ALL) - with peritonitis - with colorectal cancer Left hemicolectomies (ALL) - with peritonitis - with colorectal cancer Rectum (n=1690) Excision of rectum - with peritonitis - with colorectal cancer 3.8 5.0 11.7 14.3 4.0 3.8 2.9 2.9 4.9 10.5 5.0 5.2 5.6 6.4 5.2
Adhesion-related readmissions within 5 years of surgery (%) Possibly related 11.6 13.6 20.5 14.3 10.0 14.3 11.4 13.9 11.8 21.1 11.4 12.2 12.5 10.4 13.5 Complicated by adhesions 6.1 8.4 15.9 7.1 12.0 4.5 2.9 4.9 8.8 13.2 5.2 15.7 15.7 27.2 13.3
Reference: 1. Sunderland G. SCAR2 The risk of Adhesions Following Colorectal Surgery. Colorectal Dis 2003; 5: 598. LBA2 (Abstr.).
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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Published in: Late Breaking Abstracts 2
Surgery type
Cumulative no. and % of adhesion-related readmissions in years following surgery Year 1 Year 2 Year 3 Year 4
References:
1. Parker MC, Ellis H, Moran BJ et al. Postoperative adhesions: Ten year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum 2001; 44: 82230. 2. Wilson MS, Menzies D, Knight AD, Crowe AM. Demonstrating the clinical and cost effectiveness of adhesion reduction strategies. Colorectal Dis 2002; 4: 35560.
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Presented at: 19th European Society of Human Reproduction and Embryology Annual Meeting: xviii53 O-156 29th June - 2nd July 2003. Published in: Human Reprod 2003;18 (suppl 1): 53
Adhesion-related readmissions following gynaecological laparoscopy or gynaecological laparotomy in Scotland. An epidemiological study of 24,046 patients
Lower AM, Hawthorn RJS, Clark D, Knight AD, Crowe AM on behalf of the SCAR panel. INTRODUCTION: Adhesions are a significant cause of female infertility. Our previous research examined the burden of adhesion-related readmissions following gynaecological laparotomies conducted in Scotland in 1986. Laparoscopic surgery was in its relative infancy at the time and adhesion-related admission data were not readily identifiable. The objective of this study was to determine and compare the epidemiology of adhesion-related readmissions for gynaecological laparoscopy and laparotomy undertaken in the same year. MATERIALS AND METHODS: The Scottish morbidity record system was used to identify all gynaecological laparoscopic and laparotomy procedures (excluding caesarians) conducted in the financial year March 1996 to April 1997 and then track all adhesion-related readmissions. Laparoscopic procedures were subdivided into high risk (adhesiolysis procedures), low risk (fallopian tube sterilisation procedures), medium risk (all other procedures). Laparotomy procedures were subdivided by operation site. Adhesion-related readmissions in the subsequent four years following the initial operations were identified using OPCS4 surgical and ICD10 disease codes and categorised as either directly related, possibly related or operations not caused by adhesions but potentially complicated by them. RESULTS: A cohort of 15,197 patients undergoing laparoscopic procedures and 8,849 patients undergoing laparotomy procedures were identified. The cumulative number of readmissions either directly or possibly related to adhesions in the one to four year period following surgery are detailed below and also presented as a percentage of the initial number of surgical procedures.
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Surgery type
Cumulative no. and % of direct or possible adhesion related readmissions in years following surgery Year 1 Year 2 Year 3 Year 4
Laparoscopy - High risk - Medium risk - Low risk - OVERALL Laparotomy - Fallopian tube - Ovary - Uterus - Vagina - OVERALL 466 328 8024 31 8849 72 15.5% 59 18.0% 442 0 573 5.5% 0.0% 6.5% 705 5571 8921 15197 110 15.6% 586 10.5% 267 963 3.0% 6.3% 160 22.7% 922 16.6% 526 5.9%
203 28.8%
1203 21.6% 743 8.3%
1608 10.6%
2149 14.1%
118 25.3%
94 28.7% 716 0 8.9% 0%
928 10.5%
1219 13.8%
1462 16.5%
The number and percentage of patients readmitting one year following laparoscopic surgery were 792 (5.2%) and 433 (4.9%) following laparotomies. CONCLUSIONS: It is widely assumed that laparoscopic procedures result in fewer adhesions than laparotomies. These data support this view for laparoscopic sterilisation procedures, which form the majority of laparoscopic procedures in Scotland. Other laparoscopic procedures do however have a rate of adhesion-related readmission which is at least comparable to that for laparotomy procedures. Thus for women wishing to conceive and particularly when performing surgery of the tubes and ovaries, routine surgical practice should adopt appropriate adhesion reduction strategies. Not only may this improve pregnancy rates - but it will also reduce the wider burden of adhesion-related readmissions including pain and small bowel obstruction. Reoperative complications associated with adhesions are a rising cause of medicolegal litigation and may also be reduced.
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Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews in Gynaecological Practice, June 2003; 3 (1): 01
Adhesion-related readmissions following gynaecological laparoscopy in Scotland. An epidemiological study of 24,046 patients
Hawthorn RJS, Lower A, Clark D, Knight AD, Crowe AM, on behalf of the SCAR panel. AIM: Our previous research examined the burden of adhesions following gynaecological laparotomies undertaken in Scotland in 1986 when laparoscopic surgery was in its relative infancy. The objective of this study was to determine and compare the current epidemiology of adhesion-related readmissions for gynaecological laparoscopy and laparotomy. METHODS: From the Scottish morbidity record system we identified all gynaecological surgery (excluding caesareans) conducted in the financial year March 1996 to April 1997 and tracked subsequent adhesion-related readmissions until 2001. Laparoscopies were subdivided into high risk (adhesiolysis), low risk (tubal sterilisation), medium risk (all other procedures). Laparotomies were subdivided by operative site. Adhesionrelated readmissions were identified and categorised as either directly or possibly related, or operations not adhesion related but potentially complicated by them. RESULTS: A cohort of 15,197 patients undergoing laparoscopies and 8,849 patients undergoing laparotomies were identified. The cumulative number of readmissions and percentage of the initial surgical procedures directly/possibly related to adhesions in the four year period following surgery were identified. For the 705 high risk laparoscopies undertaken in 1996/97 there were 254 (36%) adhesion-related readmissions in the subsequent four years. For medium risk (5571) and low risk (8921) laparoscopy there were 1492 (26.8%) and 930 (10.4%) readmissions 2675 (17.6%) overall. For laparotomy patients, of the fallopian tube cohort (466) there were 178 (38.2%) readmissions compared to ovary (328) 166 (50.6%); uterus (8024) 1115 (13.9%) and vagina (31) 2 (9.7%) 1462 (16.5%) overall. CONCLUSIONS: It is widely assumed that laparoscopic procedures result in fewer adhesions than laparotomies. While these data support this view for laparoscopic sterilisations, which form the majority of laparoscopies in Scotland, other laparoscopic procedures do however have a rate of adhesion-related readmission at least comparable to that for laparotomies. Thus for women wishing to conceive, and particularly for surgery of the tubes and ovaries, surgical practice should adopt routine 39 Continued on following page...
adhesion reduction strategies. Not only may this improve pregnancy rates - but will also reduce the wider burden of adhesions including pain and small bowel obstruction. Reoperative complications associated with adhesions and laparoscopic surgery are a rising cause of medico-legal litigation which may also be reduced.
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Presented at: European Council Of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003
Adhesion related readmissions following colorectal surgery in Scotland. An epidemiological study of 4,912 patients
Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM. INTRODUCTION: Postoperative adhesions affect the health and fertility of patients, make reoperative surgery problematic and pose a significant impact on health resources. Our previous research (SCAR) demonstrated that the burden of adhesionrelated readmissions following colorectal surgery in 1986 was high. Since 1986 there have been advances in surgical techniques and anti-adhesion agents. The objective of this study was to assess the epidemiology of adhesions following colorectal surgery 10 years on. MATERIALS AND METHODS: The Scottish morbidity record system tracks all hospital readmissions on an individual patient basis. This was used to identify all patients undergoing colorectal surgery in the financial year April 1996 to March 1997 and all subsequent adhesion-related readmissions were then tracked over the following four years - categorised as either directly-related, possibly-related or operations not caused by adhesions but potentially complicated by them. RESULTS: A cohort of 4,912 colorectal patients was identified. The cumulative number of adhesion-related readmissions following surgery are presented as a percentage of the initial number of procedures in the table below.
Surgery type
Cumulative No. and % of adhesion-related readmissions in years following surgery Year 1 Year 2 Year 3 Year 4
136
2.8%
212
4.3%
287
5.8%
325
6.6%
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The year one adhesion-related readmission data for a cohort of patients undergoing colorectal surgery in 1997/98 (N=4,906) and in 1998/99 (N=4,909) demonstrated very similar rates of readmission within each readmission category. The number and percentage of patients readmitting one year following colorectal surgery were 103 (2.1%) directly related, 418 (8.5%) direct/possibly related and 853 (17.3%) for all three categories, demonstrating that for patients readmitting, up to 31% readmit more than once in the first-year following surgery due to adhesion-related problems. CONCLUSIONS: Adhesion-related readmissions following colorectal surgery in the late 1990s remains high and although the majority of readmissions occur in the first year following surgery, readmissions in subsequent years remain a significant burden. This confirms the earlier SCAR study findings and shows that despite advances in colorectal surgery since 1986 this has had little impact on the burden of adhesions. Action on adhesions has received low priority despite the potential improvements in patient outcomes, reduced healthcare costs and theatre time. Surgeons have been awaiting RCT evidence of the impact of new anti-adhesion agents on clinical outcomes before using them but our assessment of patient numbers required in such a trial (>6,000) suggests this is impractical. Pending resolution of this problem with alternate strategies, it may be appropriate to accept the use of improvements in surrogate markers of adhesion reduction as demonstration of efficacy of the simpler less expensive anti-adhesion agents.
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Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium VII Abstract VII(6)
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Surgery type
1996
1997
1998
13054
13265
12796
7.75%
7.86%
7.62%
8849
8723
8683
4.89%
4.46%
4.66%
705
852
879
11.77%
10.92%
8.76%
8921
7843
7455
2.5%
2.36%
2.37%
The variance in percentage readmissions between hospitals was lowest in lower abdominal surgery. CONCLUSIONS: Initial readmission rates due to adhesions following lower abdominal surgery or gynaecological surgery appear to be similar between years and reflect no reduction in the burden of adhesion readmissions since the original SCAR study. Highrisk laparoscopic gynaecological procedures including drainage of ovarian cysts, division of adhesions and complicated reversals of sterilisations have a higher risk but with a tendency for improvement over time.
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Presented at: European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 3-6
The burden of adhesions - evaluating the clinical impact and the value of adhesion reduction strategies
Wilson MS, Menzies D, Knight AD, Crowe AM. NB French and Spanish translations available from Shire France and Shire Iberica INTRODUCTION: To evaluate the clinical impact and value of using an adhesion reduction strategy we examined the feasibility of conducting Randomised Controlled Trials (RCT) in lower abdominal surgery to demonstrate a reduction in adhesion-related admissions following use of an adhesion reduction product. The cost effectiveness of such products was also modeled. METHODS: The number of patients required in a RCT comparing an adhesion reduction product to a control has been estimated based on 25% and 50% reductions in adhesion-related readmissions one year after surgery. A cost effectiveness model based on the Surgical and Clinical Adhesions Research Group (SCAR) database has been developed to assess the level of reduction in adhesion-related readmissions required to return the cost of investment in an adhesion reduction strategy. The cumulative costs of adhesion-related readmissions for lower abdominal surgery and the cost savings associated with an adhesion reduction policy using a low or high cost product are also assessed. RESULTS: To demonstrate a 25% reduction in the 7.2% readmissions one year after surgery (from SCAR data), it is estimated that a RCT would require between 5,686 (P=0.05, power=80%) and 7,766 (P=0.01, power=90%) lower abdominal surgery patients followed-up for one year. A cost effectiveness analysis demonstrates that routine use of adhesion reduction products costing 50 per patient will payback the cost of such investment if they reduce adhesion-related readmissions by 16% after 3 years. A product costing 200 will need to offer a 64.1% reduction in readmissions after 3 years. For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year, the cumulative costs of adhesion-related readmissions over 10 years are estimated at ~ 886 Million. DISCUSSION: Demonstrating the clinical effectiveness of adhesion reduction products in the RCT setting is unlikely to be feasible due to the large number of patients required. High priced adhesion reduction agents are unlikely to payback their direct costs. 45
Presented at : European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 7-10
The impact of adhesions following colorectal surgery today - evaluating the potential impact tomorrow
Parker MC, Wilson MS, Menzies D, Clark D, Ford I, Knight AD. NB French and Spanish translations available from Shire France and Shire Iberica INTRODUCTION: The SCAR study showed the significant burden of adhesion-related disease. While there are a number of anti-adhesion agents available, evidence that routine use will reduce the burden of disease and be cost effective is required. Modeling work has shown that randomised controlled outcome studies require large numbers of patients. A practical approach to overcoming this is to progress a study in a surgery population with an existing, reliable follow-up mechanism. To establish the feasibility of this type of study it is necessary to identify a study population and establish the variance in adhesion-related outcomes. METHODS: Using the Scottish Record Linkage database, individual patient adhesionrelated outcomes for all patients undergoing colorectal surgery (open and laparoscopic) at 6, 12, 18 and 24 months in 1996, 1997 and 1998 have been assessed. These data has been used to identify the number of hospitals required in a cluster randomisation population study to demonstrate a reduction in adhesion-related outcomes. RESULTS: The percentage of adhesion-related readmissions classified as directly or possibly related one year after open colon surgery in Scotland in 1996 (n=3199), 1997 (n=3198) and 1998 (n=3223), are as follows; 8.5% (2.9% directly, 5.6% possibly), 9.0% (3.1%, 5.9%), 9.2% (2.7%, 6.5%). The most common directly-related reoperation was freeing of adhesions. Kaplan-Meier plots of time to first adhesion-related readmissions for these colon surgery populations will be compared by cohort year and also to larger lower abdominal surgery populations. DISCUSSION: This work provides important insight to the impact that colorectal surgery today has on adhesion-related outcomes and builds on the original work undertaken in the SCAR study. The variance of adhesion-related readmission rates at a hospital level has been used to estimate the number of patients and hospital cluster sites required to progress an outcomes study. It will allow us to confirm the viability of a population based clinical outcome study.
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Presented at: The Association of Coloproctology of Great Britain and Ireland Annual Meeting, Manchester, June 2002
Adhesion related outcomes in 9,599 patients undergoing colon surgery between 1996-98
Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM. INTRODUCTION: The SCAR study showed the significant burden of adhesion-related disease. While there are a number of anti-adhesion agents available, evidence that routine use will reduce the burden of disease and be cost effective is required. Modeling work has shown that randomised controlled outcome studies are impractical because of the number of patients and length of follow-up required. A possible alternative is to progress a population based clinical outcome study. However it is necessary to identify a study population representative of the general surgical population. In undertaking this feasibility analysis important information on ongoing individual patient outcomes will be presented. METHODS: Using the Scottish Record Linkage database individual patient adhesionrelated outcomes for all patients undergoing colorectal surgery (open and laparoscopic) at 6, 12, 18 and 24 months in 1996, 1997 and 1998 have been assessed. These data has been used to identify the number of hospitals required in a cluster randomisation population study to demonstrate a reduction in adhesion-related outcomes. RESULTS: The percentage of adhesion-related readmissions classified as directlyrelated for patients undergoing open colon surgery in Scotland in 1996 (n=3192), 1997 (n=3189) and 1998 (n=3214), are as follows;
% directly adhesion-related readmissions since surgery Cohort Year 6 months 1998 1997 1996 1.2 1.2 1.2 12 months 2.3 2.3 2.1 18 months 2.7 2.5 2.9 24 months 3.1 3.1 3.3
Approximately 3 out of every 4 directly-related readmissions required reoperation within 12 months. The most common directly-related reoperation was freeing of adhesions. Details on hospital stays, morbidity and mortality will be presented. The adhesionrelated outcomes following open and laparoscopic surgery will be compared. 47 Continued on following page...
DISCUSSION: This work provides important insight to the impact that colorectal surgery today has on adhesion-related outcomes and builds on the original work undertaken in the SCAR study. The variance of adhesion-related readmission rates at a hospital level has been used to estimate the number of patients and hospital cluster sites required to progress an outcomes study. It will allow us to confirm the viability of a population based clinical outcome study.
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Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O36, 16-18 September 2004
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Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9 July 2004
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In the knowledge of the inevitability of postoperative adhesions and their serious consequences, it is time to ensure patients are advised and steps taken to protect them, including use of anti-adhesion agents, particularly in surgery known to be at high risk of adhesion formation, including: - ovarian surgery - endometriosis surgery - tubal surgery - myomectomy - adhesiolysis As surgeons we should be aware that in our increasingly litigious culture that the consequences of adhesions not only affect patients but could damage our reputation and career. Recommendations for management of adhesions recently published should now be adopted as a national policy and implemented locally to protect patients and surgeons.5
References: 1. Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update 2001; 7: 56776. 2. Wiseman D. Obtaining informed consent: patient awareness of adhesions. Adhesions News & Views 2003; 3:10-12. 3. Nash G, Pullen A. Are current surgical trainees preventing future adhesions complications? Adhesions News & Views 2002; 2:12. 4. Ellis H. Medicolegal consequences of adhesions. Hospital Medicine 2004; 65: 348-350. 5. Trew G, Lower A. Consensus in adhesion reduction management. The Obstetrician and Gynaecologist 2004; 6: S1-16.
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Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract
order to stem the increasing incidence of adhesionrelated problems and ensuing medicolegal claims.
References: 1. Menzies D, Ellis H. Intestinal obstruction from adhesions-how big is the problem? Ann R Coll Surg Engl 1990; 72: 603. 2. Nash G, Pullen A. Are current surgical trainees preventing future adhesions complications? Adhesions News & Views 2002; 2: 12. 3. Ellis H. Medicolegal c onsequences of adhesions. Hospital Medicine 2004; 65: 6:13. 4. Wiseman D. Obtaining informing consent: patient awareness of Adhesions. Adhesions News & Views 2003; 4: 10-12. 5. Trew G. Consensus in adhesion reduction management. Obstetrician & Gynaecologist (Lower A, ed) 2004; 6: 11. 6. Holmdahl L, Risberg B, Beck DE et al. Adhesions: pathogenesis and prevention-panel discussion and summary. Eur J Surg 1997; 163 (Suppl. 577): 5662. 7. Sunderland G. SCAR2 The risk of Adhesions Following Colorectal Surgery. Colorectal Dis 2003; 5: 598. LBA2 (Abstr.).
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