International Journal of Surgery 36 (2016) 233e239

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International Journal of Surgery

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Original Research

Risk factors for reoperation after ileostomy reversal e Results from a

prospective cohort study
V. Schneider a, 1, L.D. Lee a, 1, A. Stroux b, H.J. Buhr c, J.P. Ritz d, M.E. Kreis a, J.C. Lauscher a, *
a
Department of General, Visceral, and Vascular Surgery, Charit
e Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany
b
Institute of Biometry and Clinical Epidemiology, Charit
e Campus Mitte, Charit
eplatz 1, 10098 Berlin, Germany
c
German Society for General and Visceral Surgery, Schiffbauerdamm 40, 10117 Berlin, Germany
d
Department of General and Visceral Surgery, HELIOS Kliniken Schwerin, Wismarsche Strae 393-397, 19049 Schwerin, Germany

h i g h l i g h t s

Ileostomy reversal has a substantial complication rate.

Anemia and high BMI were associated with reoperations.

Optimizing patients preoperatively may decrease surgical complications.

a r t i c l e i n f o a b s t r a c t

Article history: Background: Ileostomy reversal is frequently performed in abdominal surgery. Postoperative complica-
Received 6 August 2016 tions after ileostomy reversal are encountered in around 20% of patients. Data regarding risk factors for
Received in revised form reoperation after ileostomy closure are scarce. The purpose of this prospective trial was to determine risk
1 October 2016
factors for operative revision after ileostomy closure.
Accepted 30 October 2016
Available online 1 November 2016
Materials and methods: This is an additional post hoc analysis of a two center prospective trial. After
enrollment, patient characteristics and intraoperative details were analyzed. Patients were followed up
at one postoperative visit before discharge and at a three months postoperative visit by standardized
Keywords:
Ileostomy closure
questionnaire. All reoperations occurring in the three months period after surgery were analyzed, and
Operative revision immediate reoperations which were directly related to the ileostomy reversal were analyzed separately.
Risk factors Results: 118 patients with elective ileostomy reversal were included in the trial. 12 out of 106 patients
(11.3%) underwent any reoperation within three months after surgery (Clavien-Dindo grade IIIb). On
multivariate analysis, anemia was associated with any reoperation p 0.004; OR 6.93 (95% CI 1.37
e30.07). Six out of 114 patients (5.3%) required an immediate reoperation (small bowel perforation,
anastomotic leakage, postoperative ileus, deep wound infection) due to surgical complications directly
related to the ileostomy reversal. Higher body mass index and anemia were associated with immediate
reoperations (BMI: p 0.038; OR 0.73 (95% CI 0.55e0.98); anemia: p 0.001; OR 25.50 (95% CI 3.87
e168.21).
Conclusion: Surgical complications after ileostomy reversal occurred to a substantial extent. Rate of
reoperations was associated with anemia and high body mass index. Optimizing patients in terms of
preoperative hemoglobin and BMI may reduce surgical complications after ileostomy closure.
2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

1. Introduction and ileostomy takedown. The overall postoperative morbidity is

reported as high as 17% and the mortality 0e0.6% with a rate of
Ileostomy reversal is a common procedure in colorectal surgery 7.2e7.6% for postoperative bowel obstruction, 1.4e2.0% for anas-
tomotic leak, and 1.2% for bowel perforation in systematic reviews
[1e3]. Reoperation rate after ileostomy closure was also relevant
* Corresponding author.
with 7.3% in a retrospective cohort analysis focusing on post-
E-mail address: johannes.lauscher@charite.de (J.C. Lauscher). operative complications [4]. Although the frequency of severe
1
Contributed equally to the paper.

http://dx.doi.org/10.1016/j.ijsu.2016.10.043
1743-9191/ 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
234 V. Schneider et al. / International Journal of Surgery 36 (2016) 233e239
postoperative complications after ileostomy closure is substantial,
there is little data regarding risk factors for postoperative surgical
complications.
The objective for this prospective study was to detect potential
patient-related as well as surgery-related risk factors for reopera-
tion in ileostomy reversal. Therefore, patient characteristics as well
as intraoperative factors were taken into account and the patients
were followed up for three months postoperatively to also identify
late postoperative complications.
2. Materials and methods
2.1. Trial design and participants
All data presented in this manuscript was collected for the
prospective randomized DRASTAR trial. The DRASTAR trial was a
randomized controlled two center non-inferiority trial with two
parallel groups comparing ileostomy reversal (IR) without subcu-
taneous suction drain to IR with suction drain in terms of hospital
stay, surgical site infections, colonization of the abdominal wall
with bacteria and postoperative hematomas and seromas. Block
randomization (blocks of six patients) was done directly before
surgery using an unstratied computer-generated randomization
list. The primary outcome data according to the study protocol was
published previously [5]. Here, we report a separate post hoc
analysis of this prospectively collected cohort analyzing reopera-
tions under general anesthesia. These surgical complications were
graded according to the Clavien-Dindo classication [6]; Table 1.
Patients at least 18 years old and capable to give informed
consent undergoing elective ileostomy reversal were eligible to
participate. Exclusion criterion was missing capability to give
informed consent. All ileostomies were placed in an elective setting
to protect a colorectal or coloanal anastomosis. The study protocol
was approved by the Ethics Committee of the Charite  Berlin
(Application No. EA4/120/09). This trial is registered at http://www.
ClinicalTrials.gov (ID: NCT01050686).
2.2. Enrollment, interventions and outcomes
All patients gave their written informed consent to participate
in the study at least 24 h before surgery. Patients were enrolled by
J.C.L. or L.D.L. between March 2010 and July 2013.
All operations were done in a standardized manner as described
before [5]. The ileostomy was generally closed with interrupted
sutures (Vicryl 4-0; Ethicon, Norderstedt, Germany), (except with
running sutures in 12 patients) and relocated into the abdomen. No
stapled anastomoses were done. Intraoperative bowel perforations
were either oversewn or a small bowel resection with primary
anastomosis was performed, depending on the severity of bowel
Table 1
Classication of surgical complications according to the Clavien-Dindo classication [6].
Grade Definition
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological
interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also
includes wound infections opened at the bedside.
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are
also included.
Grade III Requiring surgical, endoscopic or radiological intervention.
Grade IIIa Intervention not under general anesthesia.
Grade IIIb Intervention under general anesthesia
Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU management.
Grade IVa Single organ dysfunction (including dialysis)
Grade IVb Multiorgan dysfunction.
Grade V Death of a patient.
perforation and the perfusion of the bowel. Serosal bowel lesions
were oversewn with interrupted sutures.
The outcome was reoperation of the patient under general
anesthesia. This outcome measure was further subdivided into
immediate complications directly related to the ileostomy reversal
such as bowel perforation, anastomotic leakage, deep wound
infection and postoperative ileus and all reoperations occurring
within three months after the primary surgery. The latter includes
revisions due to complications related to the pelvic anastomosis or
complications related to the ileoanal pouch in patients with in-
ammatory bowel disease.
Patient characteristics such as age, gender, smoking, COPD,
diabetes, ASA score, anemia, renal insufciency as well as training
level of the surgeon performing the operation (staff surgeon, fellow
or resident) and intraoperative factors such as operative time,
intraoperative bowel perforation, intraoperative serosal lesion and
parastomal hernia were prospectively collected and analyzed.
Patients received a physical examination at least every second
day and at the day of discharge. A telephone interview by V. S. was
conducted three months after surgery to detect reoperation after
discharge. Data was collected on paper-based Case Report Forms
(CRFs) at time of recruitment, directly after the operation, at the
post-operative visit at time of discharge and during the telephone
interview. The CRFs were stored at the ofce for clinical trials of the
Department of Surgery I. To reduce bias, all patients meeting the
inclusion criteria who consented were prospectively enrolled.
2.3. Statistical analysis
The sample size was based on the sample size calculation to
prove the non-inferiority of the omittance of subcutaneous suction
drains with regard to hospital stay and was described before [5]. 112
patients total had to be allocated, assuming a drop out rate of 10%.
Descriptive analyses included absolute and relative frequencies
for categorical variables and mean, standard deviation, median,
range and quartiles for quantitative measurements. For categorical
outcomes, statistical group comparisons were performed using the
chi-square test or e in case of more than 25% of cells having ex-
pected frequency less than 5 e Fisher's exact test. Due to the
skewed distribution of most of the variables, group differences
concerning quantitative variables were analyzed by Mann-
Whitney-U test. Accordingly, for the association between two
quantitative variables, Spearman's rank correlation coefcient was
used. Moreover, a multiple logistic regression analysis including
potential risk factors of SSI with p < 0.25 in the univariate analysis
was conducted. Values of the multivariate analysis were expressed
as odds ratio, 95% condence interval and p-value. P-values  0.05
were considered signicant. Statistical analysis was done with IBM
SPSS Statistics 21 (IBM, Armonk, New York, USA).
 V. Schneider et al. / International Journal of Surgery 36 (2016) 233e239 235

3. Results wound infection (one case). In the group with complications not
directly related to the ileostomy reversal, there were two peri-
3.1. Patient characteristics pouchal abscesses, two peripouchal stulas, one pouchanal steno-
sis and one leakage of his pouchanal anastomosis.
Between March 2010 and July 2013, 135 patients were assessed Table 4 shows the univariate analysis of patient and operation
for eligibility. 17 patients refused to participate and 118 patients related risk factors for a reoperation within the three months
were included in the trial. One patient revoked consent after study follow-up period. Three out of seven patients with anemia were
inclusion. The characteristics of the 117 patients analyzed are revised in general anesthesia (42.9%) vs. 9/99 without anemia
depicted in Table 2. 49.6% of patients were female, the mean age of (9.1%); p 0.030. None out of 18 patients with parastomal hernia
the cohort was 49.7 years, the average BMI was 24.3 kg/m2, and 7 was reoperated and 12/87 patients without parastomal hernia
patients (6.0%) had a hemoglobin of less than 10 g/dl. The mean (13.8%); p 0.122. Multivariate analysis revealed that anemia was
operative time was 80.9 min, 5.4% of patients had a bowel perfo- the only variable with association to reoperation with an OR of 6.93
ration during the operation, and there were serosal lesions in 30.5% (95% CI 1.37e30.07); p 0.004 (Table 5).
of patients. Iatrogenic bowel perforations occurred in 4.4% of pa- A total of 114 patients could be evaluated for immediate reop-
tients operated by staff surgeons, in 4.8% of patients operated by eration. There were six patients experiencing a reoperation that
fellows and in 7.7% of patients operated by residents (p 0.830). was directly related to ileostomy reversal. Table 6 depicts the uni-
Serosal tears were caused in 28.9% of patients who were operated variate analysis for potential risk factors for these immediate sur-
by staff surgeons, in 31.0% of operations performed by fellows, and gical complications. 2.2% of patients who were operated by staff
in 30.8% of operations done by residents (p 0.959). underwent an immediate reoperation, 4.8% of patients who were
operated by fellows and 11.5% of patients who were operated by
residents (p 0.185).
3.2. Operative revisions in general anesthesia Higher BMI was associated with immediate reoperation on
univariate analysis (p 0.032). Patients who required a reoperation
106 patients (90%) could be analyzed after a three months had a BMI of 28.7 6.3 kg/m2, and patients without reoperation
period. Within the three months follow-up period, 12 patients had an average BMI of 24.1 4.0 kg/m2. Patients with immediate
(11.3%) required an operative revision in general anesthesia (Clav- revision had an average operation time for the ileostomy reversal of
ien-Dindo grade IIIb). There were no life-threatening complications 105 29.6 min, while the IR took 79.6 29.2 min in patients
with organ dysfunctions (Clavien-Dindo grade IV). Organ dys- without reoperation (p 0.028). The strongest independent vari-
functions include acute kidney injury with the need of dialysis, able associated with reoperation was anemia: Three out of seven
respiratory failure with the need of mechanical ventilation, circu- patients with anemia underwent a reoperation (42.9%) related to
latory failure, liver failure, central venous system dysfunction and the ileostomy reversal vs. three out of 107 without anemia (2.8%);
coagulopathy. There was no mortality within the three months p 0.003.
postoperative period (Clavien-Dindo grade V). Table 3 gives a On multivariate analysis for risk factors for immediate reoper-
summary about all the patients that needed a revision including the ation, operative time showed no association (p 0.294). There was
reasons for revision. In this total group of patients needing opera- a trend towards more reoperations when the primary operation
tive revision, a cohort with immediate postoperative complications was done by residents but this association did not reach signi-
(n 6; 5.3%) was subdivided. The immediate postoperative com- cance (p 0.081). Higher BMI was associated with more immediate
plications included small bowel perforation (two cases), anasto- reoperations: p 0.038; OR 0.73 (95% CI 0.55e0.98). The strongest
motic leakage (two cases), postoperative ileus (one case), and deep association was again between anemia and reoperation: p 0.001;
OR 25.50 (3.87e168.21); Table 7. If reoperations were only analyzed
for patients without anemia (n 4), there were no reoperations
Table 2
Characteristics of the entire study cohort. when the primary surgery was done by a staff surgeon, 2.6%
reoperations when the primary operation was done by a fellow and
Total patient population
12.5% reoperations when the primary operation was done by a
Female [n] 58 (49.6%) resident (p 0.031).
Diagnosis
Colon cancer [n] 2 (1.7%)
Rectal cancer [n] 34 (29.1%)
4. Discussion
Inammatory bowel disease [n] 67 (57.3%)
Other 14 (12.0%) Surgical complications leading to reoperation after ileostomy
Age [years; mean SD] 49.72 16.94 takedown were observed at a substantial rate. Data focusing on
BMI [kg/m2; mean SD] 24.31 4.25
reoperation rates after ileostomy closure is mostly derived from
Smoking [n] 19 (16.4%)
COPD [n] 2 (1.7%) small retrospective trials and therefore results differ considerably
Diabetes [n] 10 (8.6%) between trials. In a systematic review, the rate of laparotomy due to
ASA Score small bowel obstruction after ileostomy closure ranged from 0 to
ASA 1 16 (13.9%) 15%, the frequency of anastomotic leaks from 0 to 8.3%, the rate of
ASA 2 87 (75.7%)
ASA 3 12 (10.4%)
small bowel perforations from 0 to 3.2% and the rate of wound
Anemia (Hb <10 g/dl) [n] 7 (6.0%) sepsis from 0 to 18.3% [1]. Prospective data on severe surgical
Renal insufciency [n] 2 (1.7%) complications after ileostomy reversal is scarce.
Operative time [min.; mean SD] 80.89 29.66 We showed in this prospective trial with consistent technique
Training level of surgeon
and 90% follow-up that 12 patients (11.3%) required a reoperation
Staff surgeon [n] 47 (40.9%)
Fully trained surgeon/fellow [n] 42 (36.5%) within three months of postoperative follow-up. Six patients were
Resident [n] 26 (22.6%) reoperated due to a complication directly related to the ileostomy
Intraoperative bowel perforation [n] 6 (5.4%) reversal. These primary complications include bowel-related
Intraoperative serosal lesion [n] 34 (30.4%) morbidity including anastomotic leak, bowel perforation and
Parastomal hernia [n] 19 (17.0%)
postoperative ileus as well as wound infection at the ileostomy
236 V. Schneider et al. / International Journal of Surgery 36 (2016) 233e239

Table 3
Overview of all 12 patients with reoperation under general anesthesia.

Study ID Reason for revision Type of operation done Immediate complication

2 Pouchovaginal stula Transanal closure of pouchovaginal stula No

14 Pouchoanal stenosis Transanal dilatation of pouchanal stenosis No
19 Peripouchal abscess Drainage peripouchal abscess No
30 Small bowel perforation Relaparotomy, bowel resection, washout Yes
51 Pouchitis with peripouchal abscess Drainage peripouchal abscess No
52 Fistulizing pouchitis Creation of IS No
75 Postoperative ileus Relaparotomy, bowel resection Yes
80 Small bowel perforation Relaparotomy, bowel resection, washout Yes
97 Anastomotic leakage Bowel resection, creation of IS, washout Yes
98 Deep wound infection, stulizing pouchitis Wound revision, creation of an IS Yes
103 Anastomotic leakage Bowel resection, creation of IS, washout Yes
116 Leakage of pouchanal anastomosis, peritonitis Creation of IS, washout No

Table 4
Univariate analysis of independent variables for any reoperation under general anesthesia within 3 months from the ileostomy reversal.

No operative revision within 3 months Revision within 3 months P-value

Gender (n 106) 0.763

Female 46 5
Male 48 7
Diagnosis (n 106) 0.617
Colon cancer 2 0
Rectal cancer 28 2
IBD 52 9
Other 12 1
Age (n 106) 0.834
Mean Rank 54.49 60.11
BMI (n 106) 0.795
Mean Rank 53.15 55.82
Smoking (n 106) 0.686
Yes 17 1
No 77 11
COPD (n 106) 1.0
Yes 2 0
No 92 12
Diabetes (n 106) 0.593
Yes 8 0
No 86 12
ASA Score (n 106) 0.870
Mean Rank 53.35 54.50
Anemia (Hb <10 g/dl) (n 106) 0.030
Yes 4 3
No 90 9
Renal insufciency (n 106) 1.0
Yes 2 0
No 92 12
Operative time (n 106) 0.712
Mean Rank 52.35 54.61
Training level of surgeon (n 106) 0.480
Staff surgeon 35 5
Fully trained surgeon/fellow 39 3
Resident 20 4
Intraoperative bowel perforation (n 105) 0.526
Yes 5 1
No 88 11
Intraoperative serosal lesion (n 105) 1.0
Yes 29 4
No 64 8
Parastomal hernia (n 105) 0.122
Yes 18 0
No 75 12

reversal site. Six patients were reoperated due to late secondary
complications related to the pelvic anastomosis and/or related to
the ileoanal pouch. These complications include anastomotic ste-
nosis, anastomotic leak or peripouchal stula and peripouchal ab-
scess and may become apparent in mid-term or long-term course
after ileostomy takedown. Potential causes for these secondary
complications are an undetected stula of the pelvic anastomosis
before ileostomy reversal or new onset stulas or abscesses in case
of indeterminate colitis or Crohn's disease.
Complications related to the pelvic anastomosis after ileostomy
reversal are not uncommon. Rathnayake et al. found 4.4% of pouch-
anal, pouch-vaginal and recto-vaginal stulas after ileostomy
closure on follow-up in a series of 140 patients [7]. In our cohort, a
thorough endoscopy and contrast enema was performed and
 V. Schneider et al. / International Journal of Surgery 36 (2016) 233e239 237

Table 5 patient cohort (57%) suffered from inammatory bowel disease.

Multivariate analysis of independent variables for any reoperation under general Interestingly, anemia was the only independent risk factor for
anesthesia within 3 months from the primary procedure.
reoperation on multivariate analysis. We speculate that anemia
OR (95% CI) P-value with subsequently reduced tissue oxygen supply may entail an
Anemia 6.93 (1.37e30.07) 0.004 impaired immune response which may result in decreased post-
Parastomal hernia 0.54 (0.25e1.18) 0.084 operative healing.
OR: odds ratio; CI: condence interval. 5.3% of patients developed surgical complications directly
P-values <0.05 were considered signicant. related to the ileostomy closure (leak of the ileo-ileostomy, small

Table 6
Univariate analysis of independent variables for immediate postoperative reoperation under general anesthesia.

No revision for immediate postop. complication Revision for immediate postop. complication P-value

Gender (n 114) 0.680

Female 53 2
Male 55 4
Diagnosis (n 114) 0.745
Colon cancer 2 0
Rectal cancer 30 2
IBD 63 3
Other 13 1
Age (n 113) 0.525
Mean Rank 56.52 65.50
BMI (n 114) 0.032
Mean Rank 55.96 85.25
Smoking (n 113) 1.0
Yes 17 1
No 90 5
COPD (n 113) 1.0
Yes 2 0
No 105 6
Diabetes (n 113) 1.0
Yes 9 0
No 98 6
ASA Score (n 114) 0.844
Mean Rank 57.36 60.00
Anemia (Hb <10 g/dl) (n 114) 0.003
Yes 4 3
No 104 3
Renal insufciency (n 114) 1.0
Yes 2 0
No 106 6
Operative time (n 114) 0.028
Mean Rank 55.92 85.92
Training level of surgeon (n 114) 0.185
Staff surgeon 45 1
Fully trained surgeon/fellow 40 2
Resident 23 3
Intraoperative bowel perforation (n 112) 0.287
Yes 5 1
No 101 5
Intraoperative serosal lesion (n 112) 1.0
Yes 32 2
No 74 4
Parastomal hernia (n 112) 0.587
Yes 19 0
No 87 6

P-values <0.05 were considered signicant.

reviewed in every patient prior to ileostomy takedown to rule out bowel perforation, complete bowel obstruction, deep wound
stula, stricture and inammation of the anastomotic region, col- infection) that led to reoperation. Anemia was again identied to be
orectum and ileoanal pouch, respectively. The majority of our strongly associated with immediate reoperation. One retrospective
review with 152 patients also identied anemia (Hb < 11 g/dl) as
Table 7 associated with anastomotic leakage. The reoperation rate in this
Multivariate analysis of independent variables for immediate postoperative reop-
eration under general anesthesia.
retrospective cohort was 8.6% [8]. There is also evidence from an-
imal studies supporting the adverse effect of anemia on anasto-
OR (95% CI) P-value
motic healing. The anastomotic burst pressure in small as well as
BMI 0.73 (0.55e0.98) 0.038 large intestine was found to be decreased in anemic rabbits
Anemia 25.50 (3.87e168.21) 0.001 compared to non-anemic rabbits [9]. Although there is not much
Operative time 0.99 (0.96e1.02) 0.294
data to support this hypothesis to date, it is well understood that
Training level of surgeon 0.14 (0.02e1.28) 0.081
anemia leads to impaired healing of anastomoses by impaired tis-
OR: odds ratio; CI: condence interval.
sue oxygenation.
P-values <0.05 were considered signicant.
238 V. Schneider et al. / International Journal of Surgery 36 (2016) 233e239
A second patient related risk factor for an operative revision
related to ileostomy reversal was high BMI. Patients who required a
reoperation had an average BMI of 28.7 kg/m2, whereas patients
without reoperation had an average BMI of 24.1 kg/m2. Higher BMI
was associated with immediate reoperation on multivariate anal-
ysis (p 0.038). Though obesity has not been linked to severe
surgical complications after ileostomy reversal before, there is data
supporting an increased risk for severe surgical complications in
colorectal surgery for obese patients. In a recently published study,
high BMI was associated with postoperative morbidity after Hart-
mann reversal [10]. Obesity was also associated as a risk factor for
anastomotic leak after colon resection for cancer in a large multi-
centric prospective trial [11]. The lysis of adhesions in ileostomy
reversal is more complicated due to impaired overview in over-
weight patients and postoperative healing processes may also be
impaired in obese patients.
The training level of the surgeon performing the operation
showed no association with an immediate reoperation. Neverthe-
less, there was a trend towards more reoperations in patients
operated by residents in multivariate analysis but this association
did not reach signicance (p 0.081). 11.5% of patients operated by
residents underwent an immediate reoperation vs. 4.8% of patients
operated by fellows vs. 2.2% of patients operated by staff surgeons.
What is more, we detected a higher rate of reoperations in patients
primarily operated by residents who had no anemia. Reoperations
in this small subgroup (n 4) may rather be caused by technical
shortcomings than by patient related factors.
These results prove that ileostomy reversal should not be looked
upon as an easy operation. Meticulous adhesiolysis and thorough
suturing of the anastomosis is required. Residents operate under
continuous supervision of a fellow or staff surgeon in our institu-
tion. The same standards concerning steps of the operation are
always followed irrespective of surgeons' status. El-Hussuna et al.
and Habbe et al. found no association of training status of surgeon
and postoperative complication rate in ileostomy reversal [12,13].
Prolonged operative time was not a risk factor for immediate
reoperation in our cohort. Patients with immediate reoperation had
a longer average operation time for the ileostomy reversal than pa-
tients without reoperation in univariate analysis: 105 29.6 min vs.
79.6 29.2 min; p 0.028). In multivariate analysis though, pro-
longed operation time was not associated with immediate reoper-
ation: p 0.294 (OR 0.99; 95% CI 0.96e1.02). In contrast to our data,
Sharma et al. found an association between prolonged operation
time and postoperative complications [2]. Longer operative time is
multifactorial and might be caused by a more complicated operative
setting with more adhesions, a less experienced surgeon or a more
meticulous and sound preparation. In contrast to our results, higher
ASA score was associated with an increased rate of postoperative
complications before [14,15]. In these studies, also non-surgical
complications were included in the analysis. High ASA score may
have a higher impact on non-surgery related complications.
Intraoperative factors such as operative time, intraoperative
bowel perforation, intraoperative serosal lesion and parastomal
hernia were prospectively monitored. To our knowledge, factors
such as intraoperative bowel lesions with reference to reoperations
after ileostomy reversal were never evaluated in a prospective
fashion before. Interestingly, none of these factors showed an as-
sociation with immediate reoperation. If bowel lesions are imme-
diately and adequately treated with oversewing or resection, the
patient's risk for severe surgical complications does not seem to be
elevated.
4.1. Limitations
The trial was initiated and conducted as a prospective
randomized trial investigating the effect of insertion of subcu-
taneous suction drains on postoperative wound infection. Hence,
reoperation was not the primary outcome parameter of the trial.
Various surgeons with different experience performed the opera-
tion which might be a reason for bias. Loss to follow-up and missing
physical examination three months postoperatively might have
also been a source of bias. Although the generalizability is fairly
high in these prospective cohort with more than 100 study par-
ticipants operated on with a standardized technique and with a
fairly high follow-up, these limitations somewhat restrict the
generalizability of the results.
4.2. Conclusions
We showed in this prospective trial with consistent operative
technique, accurate documentation on patient characteristics and
intraoperative ndings and 90% follow-up that patient related risk
factors seem to play a more important role in risk for reoperations
than intraoperative or surgeon-related factors. While no intra-
operative factor was associated with reoperation, anemia and high
BMI were both associated with a higher rate of immediate reop-
erations. Even in ileostomy reversals which are generally not
regarded as high-risk procedures it seems to be important to
optimize the preoperative status of the patient. This trial suggests
that avoiding operations on patients with severe anemia and
encourage obese patients to lose some weight preoperatively may
decrease the risk of severe postoperative surgical complications.
Ethical approval
The study protocol was approved by the Ethics Committee of the
 Berlin (Application No. EA4/120/09).
Charite
Sources of funding
Funding of this trial was done by internal resources of both
hospitals. This research did not receive any specic grant from
funding agencies in the public, commercial, or not-for-prot
sectors.
Author contribution
Schneider V: study conception and design, acquisition of data,
interpretation of data, statistical analysis, drafting the article, nal
approval of the version to be submitted.
Dr. Lee LD: study conception and design, acquisition of data,
drafting the manuscript, nal approval of the version to be
submitted.
Stroux A: design of the trial, interpretation of data, statistical
analysis, drafting of the manuscript, nal approval of the version to
be submitted.
Prof. Dr. Buhr HJ: interpretation of data, drafting the article,
nal approval of the version to be published.
Prof. Dr. Ritz JP: study conception and design, drafting the
article, nal approval of the version to be published.
Prof. Dr. Kreis ME: analysis and interpretation of data, drafting
the article, nal approval of the version to be published.
Priv.-Doz. Dr. Lauscher JC: study conception and design,
acquisition of data, statistical analysis, interpretation of data,
drafting the article, nal approval of the version to be published.
Conicts of interest
None.
 V. Schneider et al. / International Journal of Surgery 36 (2016) 233e239
Guarantor
Priv.-Doz. Dr. JC Lauscher is the guarantor of this paper.
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