This study investigates whether prophylactic synthetic mesh placement in the retromuscular space during stoma reversal reduces the rate of stomal site incisional hernias.
Key Points
Question
Does a prophylactic retromuscular synthetic mesh during stoma reversal reduce the rate of stoma site incisional hernia after 1 year?
Findings
In this randomized clinical trial that included 79 adults, a stoma site incisional hernia after 1 year of follow-up was found in 0% of the patients receiving a prophylactic mesh vs 17.9% of the patients without prophylactic mesh.
Meaning
To prevent stoma site incisional hernias, the placement of a synthetic mesh during stoma reversal should be considered.
Abstract
Importance
Stoma reversal is associated with few complications. However, recent studies show that 1 in 3 patients develop an incisional hernia, for which half of the patients receive surgical correction.
Objective
To investigate whether prophylactic synthetic mesh placement in the retromuscular space during stoma reversal reduces the rate of stomal site incisional hernias.
Design, Setting, and Participants
This prospective, parallel, single-blinded randomized clinical trial was conducted between July 2018 and June 2023 and took place at 2 large teaching hospitals in the Netherlands. Data were analyzed from September 2024 and April 2025. Patients who underwent elective stoma reversal were included. Exclusion criteria included connective tissue disease, intraperitoneal dialysis, immunodeficiency, previous mesh placement within 3 cm of the stoma closure site, allergy or contraindication for mesh, pregnancy, and inflammatory bowel disease, as indication for initial stoma construction. Follow-up was at 30 days and 3, 6, 9, and 12 months postoperative.
Intervention
Conventional stoma closure (n = 40) vs stoma closure with preventive synthetic mesh placement in the retromuscular space (n = 39).
Main Outcomes and Measures
The primary outcome measure was radiological stoma site incisional hernia after 12 months. Secondary outcomes included postoperative complications, surgical site infections, and quality of life (measured by EuroQoL 5-Dimension, visual analog scale, 36-item short form survey, and hernia-related quality of life).
Results
A total of 88 patients were randomized to either conventional stoma closure (n = 44) or synthetic mesh-reinforced stoma closure (n = 44). At 12 months, 39 patients in the control group and 40 patients in the mesh group had completed follow-up. The rate of stoma site incisional hernia was 17.9% (n = 7) in the conventional group vs 0% (n = 0) in the mesh group (relative risk, 0.18; 95% CI, 0.034-0.330; P = .02) with a number needed to treat of 6. There was no significant difference in surgical site infections or postoperative complications. Hernia-related quality of life was significantly better at 12 months follow-up in the mesh group.
Conclusions and Relevance
In this study, placement of a prophylactic synthetic mesh in the retromuscular space prevented stoma site incisional hernias. Patients receiving a synthetic mesh experienced a better hernia-related quality of life. To prevent stoma site incisional hernias, the placement of a synthetic mesh during stoma reversal should be considered.
Trial registration
Dutch Trial Register: NL-OMON27268
Introduction
Stoma reversal is regarded as a minor and safe surgical procedure.1,2 However, during long-term follow-up, high stoma site incisional hernia (SSIH) rates have been reported.3,4,5 A large meta-analysis showed an SSIH rate of 13.1% in studies with incisional hernia rate as the primary outcome measure.3 After including colostomy reversals, radiological SSIH rates of up to 30% to 48% have been reported.5,6,7 Therefore, SSIH seems to be a highly underestimated long-term complication, which is associated with impaired health-related quality of life (QoL).8 Additionally, approximately 50% of the patients with an incisional hernia eventually require surgical intervention.7,9
Preventing the number of SSIHs could have a beneficial effect for the patient and a possible reduction in health care costs.7,9 Multiple retrospective studies have shown significantly lower SSIH rates when a prophylactic synthetic or biological mesh is placed either in the abdominal wall or intra-abdominally.10,11 The only published randomized clinical trial (RCT) on the subject showed a significant SSIH reduction after placement of an intra-abdominal biological mesh, without increasing complication rate.12 However, the mesh was placed intra-abdominally, which has a theoretical concern, as it might increase intra-abdominal adhesions. Furthermore, biological meshes are associated with higher costs and higher long-term recurrence rates compared with synthetic meshes.13,14,15
Recent retrospective studies indicate that prophylactic synthetic mesh placement during stoma closure is safe and is associated with a lower SSIH rate without increasing surgical site infection (SSI).16,17,18,19 A synthetic mesh might provide a good alternative but its efficacy has never been investigated in an RCT. The aim of this study is to investigate whether prophylactic synthetic mesh placement prevents SSIHs.
Methods
Study Design and Participants
A prospective single-blinded, parallel, superiority RCT was conducted in 2 large Dutch teaching hospitals to investigate whether prophylactic synthetic mesh placement during stoma reversal prevents the development of SSIHs compared with conventional abdominal wall closure. In both participating centers, all patients older than 18 years who underwent elective ileo or colostomy reversal were screened for eligibility. Exclusion criteria were: (1) connective tissue disease, (2) intraperitoneal dialysis, (3) immunodeficiency disease or use of immunosuppressive medication, (4) previous mesh placement in the abdominal wall within 3 cm of the stoma closure site, (5) allergy or contraindication for mesh placement, (6) pregnancy, and (7) inflammatory bowel disease, as an indication for stoma construction.
All included patients were randomly allocated 1:1 to conventional stoma closure or mesh reinforced stoma closure. Randomization was done using a computer-based algorithm (Castor EDC) on the day of surgery, which was communicated to the performing surgeon preoperatively. Patients were blinded to treatment allocation until 1-year follow-up was completed.
This trial was conducted in accordance to the Declaration of Helsinki and was approved by the local ethics committee. The study was reported according to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.20 All patients were provided with a patient information form and after reconsideration time, written informed consent was obtained. The trial was registered at the Dutch Trial Register (NL-OMON27268). After commencement of the trial (Supplement 2), 1 protocol amendment was implemented (Supplement 3). After 19 inclusions, 1 dose of prophylactic antibiotics was administered in both groups, instead of 3 doses in the intervention group. Two patients randomized to the intervention were given 3 doses of prophylactic antibiotics, as they were included before implementing the protocol amendment.
Intervention
All stoma reversals were performed by dedicated colorectal surgeons. All patients received a single dose of prophylactic antibiotics preoperatively. After construction of the anastomosis, conventional closure of the abdominal wall was performed in the control group, according to the standard procedure of the specific surgeon. In the intervention group, the posterior rectus sheath was closed with a polydioxanone suture. Thereafter, a synthetic polypropylene heavyweight (76.0 g/m2), small-pore (1.0 mm) mesh (PROLENE; Ethicon, Raritan) was placed in the retromuscular space immediately anterior to the posterior rectus sheath. The mesh was placed with an overlap of at least 3 cm at all sides of the previous stoma site. The exact size of the mesh was dependent on the size of the abdominal wall defect following stoma reversal. Four vicryl sutures were placed at the edges of the mesh securing its position. Subsequently, the anterior rectus fascia was closed, using polydioxanone sutures. In all patients, the skin was closed using the purse-string technique and, therefore, left partially open to facilitate drainage of serous fluid, avoiding seroma formation and SSIs.21 In case of a midline laparotomy as approach for stoma reversal, the midline was closed without the use of mesh, irrespective of the randomization group.
Outcomes
The primary study outcome was the radiological SSIH rate at 1 year following stoma reversal. Secondary outcomes were the clinical SSIH rate at 1-year follow-up and the number of patients requiring surgical correction. Other secondary outcomes were perioperative complications, 30-day morbidity, 30-day mortality, SSI rate, readmission rate, length of stay, and QoL at 3, 6, 9, and 12 months postoperatively. Questionnaires used were the visual analog scale to register pain and, for objectifying general QoL, both the EuroQol-5 Dimension and the 36-item short form survey were used. Lastly, for hernia-related QoL, the hernia-related quality-of-life questionnaire was sent to patients.22 For detailed information regarding outcomes and definitions, see the eMethods in Supplement 1.
Follow-Up
Outcome data were collected at 30 days postoperative and at 1 year postoperative. For all patients, an outpatient clinical visit was scheduled at least 1 year following stoma reversal to assess the presence of a clinical hernia. In addition, all patients underwent either a computerized tomography (CT) scan or an ultrasound of the abdominal wall 1-year postoperatively. Patients in whom a stoma was constructed during the treatment of a colorectal malignancy undergo regular CT scans, within the standardized Dutch follow-up scheme. These scans were used for follow-up of our primary end point to minimize radiation exposure for patients. Radiologists, whom were blinded for treatment allocation, were specifically asked to also examine the abdominal wall for signs of fascia defect or protrusion. In patients in whom a stoma was constructed and reversed due to an underlying benign disease, an ultrasound 1-year postoperatively was conducted to asses our primary outcome measure. A radiological hernia was defined as a defect of the abdominal wall at the previous stoma site visible during CT or ultrasound. Furthermore, additional abdominal CT scans or ultrasounds performed after 1-year follow-up were also reviewed and checked for radiological hernias. Lastly, all surgical corrections within the follow-up period were registered as well.
Statistical Analysis
The sample size was based on previously reported SSIH incidence rates of around 25% to 30% in patients without a prophylactic mesh vs 5% to 10% in patients with a prophylactic mesh6,7,12,23 and the estimation of detecting an absolute reduction of 22% in our primary outcome measure (SSIH difference of 5% with prophylactic synthetical mesh placement vs 27% with standard closure) with 80% power (α = .05), which required 80 patients (40 per group). To account for a potential loss of follow-up of 10%, 88 patients were recruited.
All analyses were conducted according to an intention-to-treat principle. Statistical analyses were conducted using R version 4.0.3(The R Project). Normally distributed continuous variables are expressed as mean and SD, while not normally distributed variables were expressed as median and IQR. Categorical data are presented using numbers and percentages. A 2-sided P value <.05 was considered statistically significant. The Fisher exact test or the χ2 test was used for data analysis with categorical variables and the 1-way analysis of variance test for continuous variables.
Results
Between 2018 and 2022, 175 patients were screened for participation, of whom 88 provided consent for participation (Table 1). This resulted in 44 patients in both treatment groups. Two patients did not undergo reversal after randomization, 1 due to metastasis and 1 due to adhesions. After reversal of the stoma, 4 patients received a new stoma at the old stoma site, while 3 patients were lost to follow-up. This resulted in 39 patients in the control group and 40 patients in the mesh group (Figure 1).
Table 1. Baseline Characteristics.
| Characteristic | No. (%) | |
|---|---|---|
| Control (n = 39) | Mesh (n = 40) | |
| Age, y, mean (SD) | 61 (12.8) | 66 (12.8) |
| BMI,a mean (SD) | 26 (4.2) | 26 (3.7) |
| Sex | ||
| Male | 23 (59.0) | 26 (65.0) |
| Female | 16 (41.0) | 14 (35.0) |
| ASA classification | ||
| I | 6 (15.5) | 2 (5.0) |
| II | 25 (64.0) | 27 (67.5) |
| III | 8 (20.5) | 11 (27.5) |
| Smoking | 5 (12.8) | 9 (22.5) |
| Units alcohol/week, median (IQR) | 2 (1-4) | 1 (1-5) |
| Stoma type | ||
| Loop ileostomy | 19 (48.7) | 19 (47.5) |
| Loop colostomy | 9 (23.1) | 10 (25.0) |
| Ending ileostomy | 7 (17.9) | 9 (22.5) |
| Ending colostomy | 4 (10.3) | 2 (5.0) |
| Stoma indication | ||
| LAR and loop stoma | 14 (35.9) | 14 (35.0) |
| Anastomotic leakage | 4 (10.3) | 6 (15.0) |
| Hartmann for diverticulitis | 4 (10.3) | 4 (10.0) |
| Obstruction | 6 (15.4) | 9 (22.5) |
| Perforation | 9 (23.1) | 6 (15.0) |
| Other | 2 (5.0) | 1 (2.5) |
| Colorectal cancer | 23 (59.0) | 22 (55.0) |
| Radiotherapy | 9 (23.1) | 12 (30.0) |
| Hernia cicatricalis before start of the study at another site | 1 (2.5) | 1 (2.5) |
| Days from stoma construction until reversal, median (IQR) | 144 (110-280) | 141 (108-189) |
Abbreviations: ASA, American Society of Anesthesiology; BMI, body mass index; LAR, low-anterior resection.
Calculated as weight in kilograms divided by height in meters squared.
Figure 1. Flow Figure of Included Patients.
Perioperative Results
There were no statistically significant differences between the 2 groups in terms of baseline characteristics. The stoma was reversed after a median period of 144 days vs 141 days and reversal of the stoma was performed using a local procedure in most patients (71.8% vs 75.0%). In 3 patients in the mesh group, placement of the mesh was not possible. In 2 patients, this was due to lack of retromuscular space. In another patient, the dorsal fascia was retracted, impairing closure before mesh placement. The surgeon chose not to place the mesh, as it would then be placed intra-abdominally. Median mesh size was 6 x 6 cm and median skin-to-skin time was 10 minutes longer in the mesh group (49; [IQR, 31-62] minutes vs 59 [IQR, 46-85] minutes [P = .05]). Closure of the fascia was done using a single-layer technique in 43.6% of the patients in the control group, while a double-layer technique was used in 56.4% of the patients in the control group (Table 2).
Table 2. Periperative Outcomes.
| Outcome | No. (%) | P valuea | |
|---|---|---|---|
| Control (n = 39) | Mesh (n = 40) | ||
| Approach | |||
| Local procedure | 28 (71.8) | 30 (75.0) | .25 |
| Laparoscopy | 5 (12.8) | 8 (20.0) | |
| Laparotomy | 6 (15.4) | 2 (5.0) | |
| Skin-to-skin time, min, median (IQR) | 49 (31-62) | 59 (46-85) | .05 |
| Conversion | 2 (5.1) | 1 (2.5) | .98 |
| Peroperative complications | 1 (2.6) | 0 (0.0) | .99 |
| Failure of mesh implant | NA | 3 (7.5) | NA |
| Mesh width, cm, median (IQR) | NA | 6 (6-8) | NA |
| Mesh length, cm, median (IQR) | NA | 6 (6-9) | NA |
| Surgical closure technique | |||
| Single layer | 17 (43.6) | NA | NA |
| Double layer | 22 (56.4) | NA | NA |
| 30-d Mortality | 0 | 0 | >.99 |
| 30-d Morbidity | 17 (43.6) | 13 (32.5) | .43 |
| Minor | 12 (30.0) | 9 (22.5) | .61 |
| Major | 4 (10.3) | 2 (5.0) | .65 |
| Surgical complications | |||
| Anastomotic leakage | 3 (7.5) | 1 (2.5) | .65 |
| Ileus | 10 (25.6) | 3 (7.5) | .06 |
| Bleeding | 2 (5.1) | 1 (2.5) | .98 |
| SSI | 4 (10.3) | 5 (12.5) | >.99 |
| Superficial | 3 (75.0) | 4 (80.0) | .36 |
| Deep | 1 (25.0) | 0 (0) | |
| Organ/space | 0 | 1 (20.0) | |
| Intervention for SSI | |||
| Antibiotics | 1 (25.0) | 2 (40.0) | .47 |
| Bedside drainage | 3 (75.0) | 5 (100.0) | .74 |
| Radiological drainage | 0 | 1 (20.0) | .85 |
| Surgical drainage | 1 (25.0) | 0 | .99 |
| Readmission | 2 (5.1) | 3 (7.5) | .84 |
| Length of stay, d, median (IQR) | 4 (2-7) | 4 (3-4) | .75 |
Abbreviations: NA, not applicable; SSI, surgical site infection.
Only applicable for patients in the mesh group, as failure of mesh implant and size of the mesh is only possible for patients with a mesh.
Postoperative morbidity and mortality were not statistically significantly different between the 2 groups. The rate of SSIs at the previous stoma site was 10.3% in the control group vs 12.5% in the mesh group (95% CI, −0.18 to 0.14; P < .99). Most SSIs were classified as superficial and were treated using drainage of the wound or drainage of the wound and antibiotics. One patient had a deep SSI, for which surgical drainage was necessary and 1 patient had an SSI classified as organ/space, for which radiological drainage was necessary. In the mesh group, no mesh needed to be removed in case of an SSI and all wounds healed adequately after treatment of the SSI. (Table 2).
SSIH
After 1 year, a radiologically confirmed incisional hernia was reported in 7 patients (17.9%) in the control group vs 0 patients (0%) in the mesh group (relative risk [RR], 0.18; 95% CI, 0.034-0.330; P = .02), resulting in a number needed to treat of 6. The SSIH rate was not associated with the type of closure technique in the control group after correction in a multivariable regression analysis (ie, single-layer fascia closure vs double-layer fascia closure). In both groups, 30 of the patients (75%) underwent clinical analysis at 1-year follow-up. Unfortunately, only 23 patients in both groups were physically seen at the outpatient clinic due to restricted hospital accessibility during COVID-19. Within the group of radiologically confirmed SSIHs, 6 patients (26.1%) had a clinically confirmed SSIH during physical examination and 5 patients (21.7%) had symptoms of an SSIH (Table 3; eTable 1 in Supplement 1).
Table 3. Long-Term Outcomes.
| Outcome | No. (%) | P valuea | |
|---|---|---|---|
| Control (n = 39) | Mesh (n = 40) | ||
| FU at 1 y, median (IQR) | 13.4 (11.8-15.3) | 13.6 (11.7-15.5) | .94 |
| Radiological control at 1 y | |||
| Ultrasound | 20 (50.0) | 24 (60.0) | .48 |
| CT | 19 (47.5) | 16 (40.0) | NA |
| SSIH | 7 (17.9) | 0 (0) | .02 |
| LSIH | 3 (7.7) | 1 (2.5) | .59 |
| Clinical FU at 1 y | |||
| Anamnesis | 30 (75) | 30 (75) | >.99 |
| Anamnestic SSIH | 7/30b (23.3) | 1/30b (3.3) | .06 |
| Physical examination | 23 (59.0) | 23 (57.5) | >.99 |
| SSIH at physical examination | 6/23b (26.1) | 0/23b (0.0) | .34 |
| FU at end of FU, median (IQR) | 40.4 (27.5-50.3) | 46.2 (39.6-54.7) | .26 |
| Radiological control at end of FU | |||
| No FU after 12 mo | 13 (33.3) | 17 (42.5) | .68 |
| Ultrasound | 4 (10.0) | 3 (7.5) | NA |
| CT | 22 (52.5) | 20 (50.0) | NA |
| SSIH | 8/26b (30.8) | 0/23b (0.0) | <.001 |
| LSIH | 4/26b (15.3) | 1/23b (4.3) | .38 |
| Surgical correction at end of FU | 5 (12.5) | 2 (5.0) | .43 |
| Stoma site | 3 (7.5) | 0 (0.0) | |
| Laparotomy site | 2 (5.0) | 2 (5.0) | |
Abbreviations: CT, computed tomography; FU, follow-up; LSIH, laparotomy site incisional hernia; NA, not applicable; SSIH, stoma site incisional hernia.
Only applicable for patients in the mesh group as failure of mesh implant and size of the mesh is only possible for patients with a mesh.
Includes loss to follow-up.
At the end of the follow-up, 1 or more additional radiological examinations apart from the 1-year follow-up moment were performed in 24 patients (61.5%) in the control group vs 23 patients (57.5%) in the mesh group. Including these examinations increased median follow-up to 40.4 (IQR, 27.5-50.3) months in the control group vs 46.2 (IQR, 39.6-54.7) months in the mesh group. During the increased follow-up, an SSIH was found in 8 patients (30.8%) in the control group vs 0 patients (0%) in the mesh group (RR, 0.31; 95% CI, 0.084-0.510; P = .01) (eTable 1 in Supplement 1). Lastly, 3 patients (7.5%) in the control group underwent surgical correction of the SSIH vs 0 patients (0%) in the control group (Table 3).
QoL Results
The rate of completed questionnaires did not differ significantly between the 2 groups (eTable 2 in Supplement 1). The EuroQoL 5-Dimension index score and the 36-item short form survey domains did not differ significantly (Figure 2; eFigure in Supplement 1). The cumulative score of the hernia-related quality of life was statistically significantly better after 12 months of follow-up, with a median of 86.7 (IQR, 43.3-100.0) vs 100 in the mesh group (IQR, 86.7-100.0) (P = .02) (Figure 2). Pain scores using the visual analog score were significantly higher in the control group at 9 months (7.0 [IQR, 2.0-41.0] vs 3.0 [IQR, 1.0-11.0] [P = .04]) and 12 months (10 [IQR, 3.5-27.5] vs 2.0 [IQR, 0.0-11.0] [P = .01]) (Figure 2).
Figure 2. Quality-of-Life Measurements at 0, 3, 6, 9, and 12 Months’ Follow-Up.
EQ5D indicates EuroQol 5 Dimensions; HerQLes, hernia-related quality of life survey; SF-36, 36-item short form survey; VAS, visual analog scale.
Discussion
This RCT showed a significantly lower SSIH rate in patients who received a prophylactic retromuscular mesh after 1 year. Furthermore, the number of SSIs was not statistically different between the 2 groups. Additionally, hernia-related QoL at 12 months and pain scores at 9 and 12 months were better in the mesh group.
The rate of SSIH in this study was significantly higher in patients who underwent conventional closure of the abdominal wall (17.9%) compared with mesh-reinforced closure (0%). The difference is even more pronounced when all radiological examinations until the end of follow-up were taken into account, with an SSIH rate in the control group of 30.8% vs 0% in the mesh group. These results are in line with other studies investigating the use of a prophylactic synthetic mesh during stoma reversal12,16,17,18,19,24,25,26 and the outcome could be explained by the suggestion that the previous stoma site should be considered as an incisional hernia developed, as an effect of the interruption of the abdominal wall by the stoma, that should be closed mesh-reinforced.27 This is strengthened by the fact that, for patients developing an SSIH, closure techniques were evenly spread, suggesting that adequate closure of the abdominal wall in 2 separate layers is not enough. The only RCT comparing the use of an intra-abdominal biological mesh with conventional closure after stoma reversal showed a 1-year radiological SSIH rate of 9% in the mesh group vs 21% in the control group.12 Although the SSIH rate in the control group is comparable with the current trial, the SSIH rate of 9% in the mesh group of the ROCCS trial13 is relatively high, perhaps since a biological mesh was used, which are associated with higher recurrence rates.
Placement of the mesh in the retromuscular plane was not possible in 3 cases. In 2 patients, there was lack of space in the retromuscular plane to place a mesh and in 1 patient the dorsal fascia was retracted, prohibiting adequate closure of this fascia. Given the risk of intra-abdominal adhesions, it was decided to not place the mesh. The patients that were deemed to have inadequate space in the retromuscular plane were both within the first 10 patients receiving a mesh in this study, which raises the question whether there is a learning curve for this procedure. Despite these 3 patients, all other mesh placements were not regarded as difficult as shown by the average additional operating time of 10 minutes.
Although the use of a synthetic mesh has a theoretical higher risk of developing an SSI, given the clean-contaminated nature of the procedure,28 no significant difference regarding SSI rate was found in this study. This is in concordance with previous studies investigating the use of a prophylactic synthetic mesh.16,17,18,19 Furthermore, SSI rates are in line with studies investigating stoma reversal without prophylactic mesh placements.2,29,30 Nevertheless, as this trial is not powered to prove a difference in the SSI rate, additional studies should further investigate this. One case in the control group experienced a deep SSI, while 1 case in the mesh group experienced an SSI confined to an organ/space. The first was surgically drained and the latter was radiologically drained. In all of the other cases, drainage of the wound, sometimes combined with antibiotics, was enough to treat the infection and removal of the mesh was never necessary. This could be explained due to the location of the mesh in the well-vascularized retromuscular plane with closed dorsal and ventral fasciae. The retromuscular position preserves the perforating vessels entering the rectus sheath anteriorly, which could in turn help the secondary healing of the skin surrounding the purse string.17
This study also showed a significantly better hernia-related QoL in the mesh group after 12 months. This can be attributed to the 0% SSIH rate in the mesh group, leading to a higher hernia-related QoL. This did not lead to a significant difference in general QoL, as measured by the 36-item short form survey or EuroQoL 5-Dimension, which is in accordance with the only other study evaluating QoL after mesh reinforced closure of the abdominal wall during stoma reversal.12 Most likely, general health is influenced by many variables, including SSIH. Other variables include, but are not limited to, psychological health, comorbidities, and social economic status.
Strengths and Limitations
To our knowledge, this is the first RCT showing a significant reduction in SSIH after prophylactic synthetic mesh placement in the retromuscular plane during stoma reversal, with an increased hernia-related QoL after 12 months. Nevertheless, certain limitations should be taken into account. First, surgeons participating in this trial were not blinded as this was not possible. However, the primary outcome measurement was an objective outcome analyzed by blinded radiologists. Second, our primary outcome was the SSIH rate after 12 months of follow-up. Even though it is known that 75% of SSIH develop within 1 year after stoma reversal,18 an SSIH might also develop after more than 12 months of follow-up. Therefore, a secondary outcome including all radiological examinations at the end of follow-up was reported. Third, our primary outcome measure was defined as a radiological SSIH, instead of a clinical or symptomatic SSIH. We chose a radiological SSIH as this is a well-defined outcome measure that can be objectified by a radiologist. Additionally, it is suggested that a 1-year radiologically detected SSIH serves as a precursor for a 2-year clinical SSIH.12,31 Fourthly, after 19 inclusions the amount of prophylactic antibiotic doses in the intervention group was changed from 3 to 1. Two of these patients were actually given 3 doses of antibiotics. Although this theoretically could have influenced our results, given the amount of patients influenced by the amendment, this will probably not have changed outcomes. Lastly, although it was our intention to record the number of clinical SSIH, due to the COVID-19 pandemic, physical outpatient visits during the follow-up were restricted, thereby, limiting the generalizability of this outcome.
Conclusions
This multicenter RCT showed that closure of the abdominal wall with a retromuscular synthetic mesh leads to a lower SSIH rate, with a number needed to treat of 6. Subsequently, a significantly higher in hernia-related QoL was found. As several other trials are currently recruiting, the outcomes of these trials should be awaited.32,33,34 Future research should include long-term follow-up, as well as safety and cost-effectiveness analyses.
eMethods
eFigure 1. Quality of life, measured using the SF-36 domains at 0, 3, 6, 9 and 12 months follow up
eTable 1. Stoma site incisional hernia characteristics
eTable 2. Completion of questionnaires
Research protocol first version
Research protocol last version
Data sharing statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eMethods
eFigure 1. Quality of life, measured using the SF-36 domains at 0, 3, 6, 9 and 12 months follow up
eTable 1. Stoma site incisional hernia characteristics
eTable 2. Completion of questionnaires
Research protocol first version
Research protocol last version
Data sharing statement
