Impact of parastomal hernia on colostomy costs at 1 year: Secondary analysis of a randomized clinical trial (STOMAMESH).

BACKGROUND AND AIMS: Parastomal hernia (PSH) is a common complication after the creation of a colostomy, with a prevalence of approximately 50%. Despite the high frequency, little is known how PSH affects the cost of colostomy care.The hypothesis in this study was that PSH increases the cost of colostomy care compared with not having a PSH. METHODS: Two groups with (N = 61) and without (n = 147) PSH were compared regarding costs of stoma appliances and visits. The population from a large randomized trial comparing construction of colostomy with or without prophylactic mesh (STOMAMESH) was used and cross-matched with health economic data from the National Pharmaceutical Register, 1 year after initial surgery. RESULTS: Patients with and without a PSH were similar in basic demographic data. No difference in cost of stoma appliances (with PSH 2668.3 EUR versus no PSH 2724.5 EUR, p = 0.938) or number of visits to a stoma therapist (p = 0.987) was seen, regardless of the presence or not of a PSH. CONCLUSIONS: PSH appears not to affect costs due to colostomy appliances or the need to visit a stoma therapist, in the first year. The lesson to be learnt is that PSHs are not a driver for costs. Other factors may be determinants of the cost of a colostomy, including manufacturers' price and persuasion, means of procurement, and presence of guidelines.

No Reduction in Parastomal Hernia Rate 3 Years After Stoma Construction With Prophylactic Mesh: Three-year Follow-up Results From STOMAMESH-A Multicenter Double-blind Randomized Controlled Trial.

OBJECTIVE: The primary objective was to compare rates of parastomal hernia (PSH) 3 years after stoma construction with prophylactic mesh or no mesh. A secondary objective was to compare complications requiring reintervention within 3 years. BACKGROUND: Recent studies have shown that a prophylactic mesh does not reduce the rate of PSH contrary to older studies. Long-term data on efficacy and safety is however scarce. METHODS: A randomized controlled double-blind multicenter trial. Patients planned for permanent end colostomy were randomized to either prophylactic mesh in the retromuscular position around the stoma site or no mesh. They were evaluated for PSH clinically and with computed tomography (CT) 3 years after stoma construction. Medical records of all patients included were also reviewed at 3 years to detect any abdominal or abdominal wall surgery during that period. RESULTS: A total of 232 patients were randomized. At 3 years, 154 patients were available for clinical evaluation and 137 underwent a CT scan. No significant difference in PSH rates was seen between the treatment allocation arms (clinical: P =0.829 and CT: P =0.761, respectively), nor was there a significant difference in the number of reinterventions, but 2 patients had their mesh removed at emergency surgery. CONCLUSIONS: Prophylactic mesh does not reduce the rate of PSH and cannot be recommended for routine use.

EHS Rapid Guideline: Evidence-Informed European Recommendations on Parastomal Hernia Prevention-With ESCP and EAES Participation.

Background: Growing evidence on the use of mesh as a prophylactic measure to prevent parastomal hernia and advances in guideline development methods prompted an update of a previous guideline on parastomal hernia prevention. Objective: To develop evidence-based, trustworthy recommendations, informed by an interdisciplinary panel of stakeholders. Methods: We updated a previous systematic review on the use of a prophylactic mesh for end colostomy, and we synthesized evidence using pairwise meta-analysis. A European panel of surgeons, stoma care nurses, and patients developed an evidence-to-decision framework in line with GRADE and Guidelines International Network standards, moderated by a certified guideline methodologist. The framework considered benefits and harms, the certainty of the evidence, patients' preferences and values, cost and resources considerations, acceptability, equity and feasibility. Results: The certainty of the evidence was moderate for parastomal hernia and low for major morbidity, surgery for parastomal hernia, and quality of life. There was unanimous consensus among panel members for a conditional recommendation for the use of a prophylactic mesh in patients with an end colostomy and fair life expectancy, and a strong recommendation for the use of a prophylactic mesh in patients at high risk to develop a parastomal hernia. Conclusion: This rapid guideline provides evidence-informed, interdisciplinary recommendations on the use of prophylactic mesh in patients with an end colostomy. Further, it identifies research gaps, and discusses implications for stakeholders, including overcoming barriers to implementation and specific considerations regarding validity.

Update Systematic Review, Meta-Analysis and GRADE Assessment of the Evidence on Parastomal Hernia Prevention-A EHS, ESCP and EAES Collaborative Project.

Objective: To perform a systematic review and meta-analysis on the effectiveness of prophylactic mesh for the prevention of parastomal hernia in end colostomy, with the ultimate objective to summarize the evidence for an interdisciplinary, European rapid guideline. Methods: We updated a previous systematic review with de novo evidence search of PubMed from inception up to June 2022. Primary outcome was quality of life (QoL). Secondary outcomes were clinical diagnosis of parastomal hernia, surgery for parastomal hernia, and 30 day or in-hospital complications Clavien-Dindo ≥3. We utilised the revised Cochrane Tool for randomised trials (RoB 2 tool) for risk of bias assessment in the included studies. Minimally important differences were set a priori through voting of the panel members. We appraised the evidence using GRADE and we developed GRADE evidence tables. Results: We included 12 randomized trials. Meta-analysis suggested no difference in QoL between prophylactic mesh and no mesh for primary stoma construction (SMD = 0.03, 95% CI [-0.14 to 0.2], I2 = 0%, low certainty of evidence). With regard to parastomal hernia, the use of prophylactic synthetic mesh resulted in a significant risk reduction of the incidence of the event, according to data from all available randomized trials, irrespective of the follow-up period (OR = 0.33, 95% CI [0.18-0.62], I2 = 74%, moderate certainty of evidence). Sensitivity analyses according to follow-up period were in line with the primary analysis. Little to no difference in surgery for parastomal hernia was encountered after pooled analysis of 10 randomised trials (OR = 0.52, 95% CI [0.25-1.09], I2 = 14%). Finally, no significant difference was found in Clavien-Dindo grade 3 and 4 adverse events after surgery with or without the use of a prophylactic mesh (OR = 0.77, 95% CI [0.45-1.30], I2 = 0%, low certainty of evidence). Conclusion: Prophylactic synthetic mesh placement at the time of permanent end colostomy construction is likely associated with a reduced risk for parastomal hernia and may confer similar risk of peri-operative major morbidity compared to no mesh placement. There may be no difference in quality of life and surgical repair of parastomal hernia with the use of either approach.

Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial.

BACKGROUND: There are several surgical options for the management of pilonidal disease, including midline and off midline closure, but prospective studies are rare. The study hypothesis was that Karydakis flap surgery would result in shorter wound healing and fewer recurrences than excision of pilonidal sinus and suture in the midline. METHODS: A randomized clinical trial was conducted in two hospitals in Sweden between 2006 and 2015 to compare excision and suture in the midline with Karydakis flap surgery. Adult patients with a chronic pilonidal sinus disease were randomized 1:1 at the outpatient clinic without blinding. Power calculation based on recurrence of 2 per cent for Karydakis flap and 10 per cent for excision and primary closure in the midline required 400 patients with 90 per cent statistical power at 5 per cent significance assuming 10 per cent loss during follow-up. Participants were followed up until complete wound healing; late follow-up after 6-13 years was performed by telephone by two blinded assessors. The two co-primary outcomes were time to complete wound healing and recurrence rate. RESULTS: The study was terminated early at a planned interim analysis due slow recruitment and a significant difference in primary outcome. In total, 125 patients were randomized, of whom 116 were available for the present analysis. Median wound healing time was 49 days (95 per cent confidence interval (c.i.) 32 to 66) for excision with suture in the midline and 14 days (95 per cent c.i. 12 to 20) for Karydakis flap surgery (P < 0.001). There were five recurrences in each group, after a median follow-up of 11 years (P = 0.753). CONCLUSION: Karydakis flap surgery for pilonidal sinus disease led to a shorter wound healing time than excision and suture in the midline but no difference in recurrence rates.Registration number: NCT00412659 (http://www.clinicaltrials.gov).

Use of Prophylactic Mesh When Creating a Colostomy Does Not Prevent Parastomal Hernia: A Randomized Controlled Trial-STOMAMESH.

OBJECTIVE: The aim of this study was to determine whether parastomal hernia (PSH) rate can be reduced by using synthetic mesh in the sublay position when constructing permanent end colostomy. The secondary aim was to investigate possible side-effects of the mesh. BACKGROUND: Prevention of PSH is important as it often causes discomfort and leakage from stoma dressing. Different methods of prevention have been tried, including several mesh techniques. The incidence of PSH is high; up to 78%. METHODS: Randomized controlled double-blinded multicenter trial. Patients undergoing open colorectal surgery, including creation of a permanent end colostomy, were randomized into 2 groups, with and without mesh. A lightweight polypropylene mesh was placed around the colostomy in the sublay position. Follow up after 1 month and 1 year. Computerized tomography and clinical examination were used to detect PSH at the 1-year follow up. Data were analyzed on an intention-to-treat basis. RESULTS: After 1 year, 211 of 232 patients underwent clinical examination and 198 radiologic assessments. Operation time was 36 minutes longer in the mesh arm. No difference in rate of PSH was revealed in the analyses of clinical (P = 0.866) and radiologic (P = 0.748) data. There was no significant difference in perioperative complications. CONCLUSIONS: The use of reinforcing mesh does not alter the rate of PSH. No difference in complication rate was seen between the 2 arms. Based on these results, the prophylactic use of mesh to prevent PSH cannot be recommended.