Methods of Colostomy Construction: No Effect on Parastomal Hernia Rate

Abstract

Objective: The primary objective of this trial was to compare the parastomal hernia rates 1 year after the construction of an end colostomy by 3 surgical techniques: cruciate incision, circular incision in the fascia and using prophylactic mesh. Secondary objectives were evaluation of postoperative complications, readmissions/reoperations, and risk factors for parastomal hernia. Summary of Background Data: Colostomy construction techniques have been explored with the aim to improve function and reduce stoma complications, but parastomal herniation is frequent with an incidence of approximately 50%. Methods: A randomized, multicenter trial was performed in 3 hospitals in Sweden and Denmark; all patients scheduled to receive an end colostomy were asked to participate. Parastomal hernia within 12 months was determined by computed tomography of the abdomen in prone position and by clinical assessment. Complications, readmissions, reoperations, and risk factors were also assessed. Results: Two hundred nine patients were randomized to 1 of the 3 arms of the study. Patient demographics were similar in all 3 groups. Assessment of parastomal hernia was possible in 185 patients. The risk ratio (95% confidence interval) for parastomal hernia was 1.25 (0.83; 1.88), and 1.22 (0.81; 1.84) between cruciate versus circular and cruciate versus mesh groups, respectively. There were no statistically significant differences between the groups with regard to parastomal hernia rate. Age and body mass index were found to be associated with development of a parastomal hernia. Conclusion: We found no significant differences in the rates of parastomal hernia within 12 months of index surgery between the 3 surgical techniques of colostomy construction.

A semi‐Markov model comparing the lifetime cost‐effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer

“…[Correction added on 05 October 2021 after first online publication: In the preceding line, >-0.97 and >-0.94 hve been corrected to >-0.95 and >-0.93 respectively in this version.] We note that three [5,34,44] of the four largest multicentre RCTs did not provide strong evidence to exclude the possibility that synthetic mesh has no effect in reducing the incidence of PSH. In contrast, the fourth RCT [2] reported a much lower rate of PSH incidence in the group who received prophylactic mesh.…”

“…Those who survived then entered the Markov model via the "No PSH" health state. Based on data from several RCTs [2,28,[34][35][36], the mean age of the patient cohort was estimated to be 65 years at the index operation and the gender ratio was approximately 65% male to 35% female. Patients in whom PSH developed moved into the "PSH" health state.…”

“…A recently published Cochrane review and meta-analysis of 10 RCTs (771 patients) reported a reduction in the incidence of PSH in patients who had a prophylactic mesh placed during the index operation compared with no mesh [15]. However, new evidence has emerged from three more RCTs [34,44,52] since the Cochrane review. Furthermore, the Cochrane review did not analyse the incidence of PSH by synthetic and biologic mesh types.…”

Use of prophylactic mesh during initial stoma creation to prevent parastomal herniation: a systematic review and meta‐analysis of randomised controlled trials

“…This current review and meta-analysis, which has included all recent larger multicentre RCTs (n = 3) [5,35,36], has synthesised data from 13 RCTs (1070 patients) and found a reduced risk of PSH incidence in patients with mesh than without mesh Fleshman 2014 [46] Jänes 2009 [43] López-Cano 2012 [49] López-Cano 2016 [50] Odensten 2019 [5] Prudhomme 2021 [36] Serra-Aracil 2009 [51] Vierimaa 2015 [37] Total Heterogeneity: I 2 = 6%, W 2 = 0.0579, p = 0.39…”

Collaboration in colorectal surgical research

“…The network was initially led by the two founders, with meetings of all participants (including research nurses, statisticians and administrative personnel) being held at least bi‐annually. At the meetings, research ideas were transformed into randomized controlled trials, such as DIverticulitis ‐ LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis (DILALA) [6], EArly cloSure of temporary ileostomY (EASY) [5] and the technical aspects of STOMA CONSTruction (Stoma‐Const) [9], and also into large prospective cohort studies, such as Quality of Life in RECTal cancer (QoLiRECT) [10] and Quality of Life in COLon cancer (QoLiCOL) [11]. The study protocols were drafted within the network, and all interested participants in the network were given the opportunity to revise the protocols.…”