Hernia (2023) 27:657–664 https://doi.org/10.1007/s10029-023-02781-4 ORIGINAL ARTICLE Parastomal hernia prevention with permanent mesh in end colostomy: failure with late follow‑up of cohorts in three randomized trials M. López‑Cano1,3 · M. Adell‑Trapé1 · M. Verdaguer‑Tremolosa1 · V. Rodrigues‑Gonçalves1 · J. Badia‑Closa2 · X. Serra‑Aracil2 Received: 23 October 2022 / Accepted: 14 March 2023 / Published online: 25 March 2023 © The Author(s) 2023 Abstract Purpose Short-term results have been reported regarding parastomal hernia (PH) prevention with a permanent mesh. Long- term results are scarce. The objective was to assess the long-term PH occurrence after a prophylactic synthetic non-absorbable mesh. Methods Long-term data of three randomized controlled trials (RCTs) were collected. The primary outcome was the detec- tion of PH based exclusively on a radiological diagnosis by computed tomography (CT) performed during the long-term follow-up. The Kaplan–Meier method was used for the comparison of time to diagnosis of PH according to the presence of mesh vs. no-mesh and the technique of mesh insertion: open retromuscular, laparoscopic keyhole, and laparoscopic modi- fied Sugarbaker. Results We studied 121 patients (87 men, median age 70 years), 82 (67.8%) of which developed a PH. The median overall length of follow-up was 48.5 months [interquartile range (IQR) 14.4–104.9], with a median time until PH diagnosis of 17.7 months (IQR 9.3–49.0). The survival analysis did not show significant differences in the time to development of a PH according to the presence or absence of a prophylactic mesh neither in the overall study population (log-rank, P = 0.094) nor in the groups of each technique of mesh insertion, although according to the surgical technique, a higher reduction in the appearance of PH for the open retromuscular technique was found (log-rank, P = 0.001). Conclusion In the long-term follow-up placement of a non-absorbable synthetic prophylactic mesh in the context of an elec- tive end colostomy does not seem effective for preventing PH. Keywords Parastomal · Hernia · Prevention · Mesh Introduction Development of parastomal hernia (PH) after intestinal stoma creation continues to be a matter of concern due to its high prevalence [1], marked impact on the patient’s quality M. López-Cano, M. Adell-Trapé contributed equally to the study and share first authorship credit. of life [2], and poor results associated with surgical hernia repair both in the short term [3] and long term [4]. There * M. López‑Cano has been a renewed interest especially in the last decade, to mlpezcano@gmail.com establish preventive methods of PH formation, in particular 1 Abdominal Wall Unit, Department of General Surgery, using a prophylactic non-absorbable synthetic mesh during Hospital Universitari Vall d’Hebron, Universitat Autònoma end colostomy formation in elective surgical contexts [5]. de Barcelona, Barcelona, Spain In this setting, the results of systematic reviews and meta- 2 Department of General and Digestive Surgery, Colorectal analyses of randomized controlled trials (RCTs) of diverse Unit, Parc Taulí University Hospital, Universitat Autònoma methodological quality have consistently shown the useful- de Barcelona, Sabadell, Barcelona, Spain ness of this type of mesh in the prevention of PH [6]. More- 3 Abdominal Wall Unit, Department of General Surgery, over, benefits of prophylactic mesh placement have been Hospital Universitari Vall d’Hebron, Passeig Vall d’Hebron supported by the recommendation of the European Hernia 119‑129, 08035 Barcelona, Spain 13 Vol.:(0123456789) 658 Hernia (2023) 27:657–664 Society (EHS) published in 2018 for the use of prophylactic 27 allocated to the intervention (mesh) and 27 to the con- mesh when an elective permanent end colostomy is con- trol group. Patients were scheduled for permanent end structed [7]. However, between 2019 and 2022, there has colostomy surgery to treat cancer of the lower third of been an important controversy based on negative findings of the rectum. A permanent synthetic lightweight mesh was three RCTs [8–10] and one meta-analysis [11] as opposed to inserted in the retromuscular position (open approach) positive results of an updated systematic review and meta- in the intervention group. Computed tomography (CT) analysis of all previous RCTs published in the literature [12]. evaluation of the presence of PH revealed 14/27 (44.4%) In review, it was concluded that there remains a significant hernias in the control group and 6/27 (22.2%) in the mesh reduction in the risk of PH with the use of prophylactic mesh group (P = 0.083), whereas by clinical assessment, 11/27 at the time of end colostomy formation [12]. (40.7%) PH were diagnosed in the control group and 4/27 It is possible that an important drawback in the inter- (14.8%) in the mesh group (P = 0.033). pretation of the past and recent evidence may be related In the second RCT [18], 36 patients were randomized, 19 to the short follow-up of RCTs published so far [11, 12], to the mesh group and 17 to the control group. The study with a prolonged follow-up in only four studies [13–16]. On population included rectal cancer patients undergoing the other hand, a further difficulty in the interpretation of elective laparoscopic abdominoperineal resection with findings is the use of different surgical techniques for mesh permanent colostomy. A large-pore lightweight compos- placement, with the most frequent being a retromuscular ite mesh in the intraperitoneal/onlay position was inserted position using an open approach (laparotomy) or an intra- by laparoscopic approach in patients randomized to the peritoneal position using a laparoscopic approach (keyhole intervention group. The mesh had a cruciate incision on or modified Sugarbaker) [5, 12]. the center to allow the colon passage through that opening In the previous context, the main objective of this study (keyhole). PH was defined radiologically by a CT scan was to assess the long-term effectiveness of the use of pro- performed 12 months after surgery. PH detected in 50% phylactic mesh at the time of elective end colostomy for- of patients in the mesh group and in 93.8% of patients in mation based on a pooled analysis of three RCTs [17–19], the control group (P = 0.008). published by two different groups of the same geographical In the third RCT [19] rectal cancer patients undergoing area and using three different procedures: open retromuscu- laparoscopic abdominoperineal resection with permanent lar [17], laparoscopic keyhole [18], and laparoscopic modi- colostomy were randomized to the mesh group (n = 24) or fied Sugarbaker [19]. to the control group (n = 28). In the intervention group, a prophylactic permanent synthetic composite lightweight mesh, without incisions on its surface, was placed intra- Methods peritoneally using a laparoscopic approach. The mesh was positioned on the lateralized colon covering the stoma Between 2009 and 2016, three RCTs carried out by two orifice. In this way a tunnel between the abdominal wall independent collaborative groups in acute-care tertiary hos- and the prosthesis was created (modified Sugarbaker pitals located in the same geographical area, reported short- technique). After CT examination, 6/24 PHs (25%) were term outcomes (maximum 2 years) of the use of a permanent observed in the mesh group compared with 18/28 (64.3%) prophylactic synthetic mesh for preventing PH in patients in the non-mesh group (P < 0.005). with definitive end colostomy. Two studies were single- center trials [17, 18] and the third study was a multicenter The present study included all patients from the afore- trial [19]. In all three trials, patients were randomly assigned mentioned three RCTs. The primary outcome was the detec- with a 1:1 allocation ratio to mesh placement (intervention tion of PH based exclusively on a radiological diagnosis by group) versus no-mesh (control group) at the time of elec- CT examination performed over the long-term follow-up tive surgery. The study design, the surgical procedure, and of patients. CT scans were performed in the supine posi- approval by the institutional review board of the three trials tion, with the patient at rest, and with intravenous contrast. were reported in the corresponding publications of short- Because no consistent radiological criteria for PH have term results. Patients included in the three trials were ini- been used in different studies [17–19], we here considered a tially informed of the possibility of participating in a retro- wide definition of PH to describe a loop of intestine or any spective study aimed to collect long-term follow-up data. abdominal organ, as well as preperitoneal fat, protruding Briefly, and by chronological order, salient features of through the defect alongside the ostomy. All CTs were evalu- these three RCTs are here described: ated by a single experienced radiologist who was unaware of the surgical technique used for mesh placement. The first RCT [17] analyzed the prevalence of PH after The start of follow-up was considered as the date of CT colostomy placement. Fifty-four patients were included, examination from which the short-term data were extracted 13 Hernia (2023) 27:657–664 659 in the original studies [17–19], and the end of follow-up patients developed a PH (30 in the mesh group and 52 in (whether the patient was alive or death) as the date of the last the non-mesh group), with a total rate of PH of 67.8%. The CT scan performed. All patients lost to long-term follow-up median overall length of follow-up was 48.5 months (IQR for any reason were excluded. The patients were not clini- 14.4–104.9 months), with a median time until diagnosis cally evaluated given the interobserver variation of the clini- of PH of 17.7 months (IQR 9.3–49.0 months). cal diagnosis in the case of PH [20], considering the CT scan The distribution of variables according to the surgi- as the most objective procedure for the purpose of this study cal technique of mesh insertion is shown in Table 1. The [21]. The secondary outcome of the study was the number of percentage of male patients was significantly higher in patients with PH requiring surgical hernia repair. the modified Sugarbaker group as compared to the other groups (P = 0.008) and the rate of PH was significantly Statistical analysis higher in the keyhole group (P = 0.008). Also, the length of follow-up was significantly longer in the keyhole group Categorical variables are expressed as frequencies and per- (P = 0.003), but time to appearance of PH was significantly centages, and continuous variables as mean and standard shorter in this group (P = 0.011). The mortality rate was deviation (SD) or median and interquartile range (IQR) also higher in the keyhole group (P = 0.049). The com- (25th–75th percentiles) as appropriate. Differences in the parison of variables according to the presence of mesh distribution of variables (demographic data, body mass vs. non-mesh in the three surgical techniques of mesh index [BMI], occurrence of PH, length of follow-up, and insertion is shown in Table 2. In the mesh group, 100% mortality) between patients in the mesh and non-mesh (con- of patients undergoing mesh insertion using the keyhole trol) groups, as well as according to the surgical technique of technique developed a PH as compared to 55.6% in the mesh insertion, were analyzed with the chi-square test or the modified Sugarbaker group and 45% in the retromuscular Fisher’s exact test for categorical data, and the Mann–Whit- group (P = 0.005). The keyhole group showed a higher ney U test for continuous data. The Kaplan–Meier method length of overall follow-up (P = 0.001) and a shorter time was used for the comparison of survival times (time to until development of PH (P = 0.089). The mortality rate diagnosis of PH) according to the presence of mesh and was also significantly higher among non-mesh controls of the surgical technique used for mesh insertion. Differences the keyhole group (P = 0.027). in survival were analyzed with the log-rank test. Statisti- The survival analysis did not show significant differ- cal significance was set at P < 0.05. The SPSS version 26.0 ences in the time to development of a PH according to the (IBM Corp., Armonk, NY, USA) was used for data analysis. presence or absence of a prophylactic mesh, neither in the overall study population (log-rank, P = 0.094) (Fig. 1a) nor in the groups of each mesh insertion technique (Fig. 1b, c, Results d). Figure 2 shows the results of survival analysis accord- ing to the presence or absence of mesh and the surgical Of a total of 184 patients included in the three RCTs, 63 procedures in the overall study population (Fig. 2a), with a were excluded from the analysis due to insufficient data in higher reduction in the appearance of PH for the retromus- 44 and lost to follow-up in 19.Therefore, the study popu- cular technique (log-rank, P = 0.001) (Fig. 2b). Differences lation consisted of 121 patients (65.8%), 87 men and 34 among surgical procedures in the group without mesh were women, with a median age of 70 years (IQR 61–76 years) not statistically significant (Fig. 2c). and BMI of 26.3 kg/m2 (IQR 24.2–28.6 kg/m2). Eighty-two Table 1  Variables distribution according to the surgical technique of mesh insertion Study group (N:121) Modified sugarbaker (N:44) Keyhole (N:33) Retromuscular (N:44) P value Mesh [yes (%)] 18 (40.9) 11 (33.3) 20 (45.5) 0.561 Woman (%)/men (%) 8 (18.2)/36 (81.8) 16 (48.5)/17 (51.5) 10 (22.7)/34 (77.3) 0.008 Age years, median(IQR) 72 (60–78) 72 (66–75) 67 (61–73) 0.280 BMI, median(IQR) 26.2 (24.2–28.0) 26.9 (24.7–29.0) 26.6 (24.2–29.0) 0.540 PH, N (%) 29 (65.9) 29 (87.9) 24 (54.5) 0.008 Months to PH, median(IQR) 17.9 (9.4–41.8) 14.5 (8.1–20.7) 24.7 (11.3–92.4) 0.011 Exitus, N (%) 19 (43.2) 18 (54.5) 12 (27.3) 0.049 Months of follow- up, median(IQR) 30.1 (12.9–70.3) 104.2 (32.3–140.1) 42.2 (11.3–138.8) 0.003 P probability, IQR interquartile range, BMI body mass index, PH parastomal hernia 13 660 Hernia (2023) 27:657–664 Table 2  Variables comparison according to the presence mesh vs. non-mesh in the three surgical techniques Study group 121 Patients Subgroup Mesh (n:49) P No mesh (n:72) P Type of tech- Mod Sugarbaker Keyhole Retromuscular Mod Sugarbaker Keyhole Retromuscular nique N (%) 18 (37) 11 (22) 20 (41) 26 (36) 22 (31) 24 (33) Age years, 74 (60.7–78.5) 72 (66–75) 69.5 (60.2–73.0) 0.343 70 (58.2–78.0) 71.5 (66.2–77.5) 64.5 (62–74.7) 0.501 median (IQR) BMI, median 26 (24.5–27.9) 25.8 (23.3–27.3) 26.1 (24.2–28.4) 0.782 26.3 (22.4–28.3) 27.6 (25.3–29.2) 27.3 (24.2–29.3) 0.411 (IQR) PH, N (%) 10 (55.6) 11 (100.0) 9 (45.0) 0.005 19 (73.1) 18 (81.8) 15 (62.5) 0.341 Months to PH, 20.5 (15.9–60.5) 13.3 (6.6–30.2) 50.4 (11.6–88.1) 0.089 12.7 (8.6–31.1) 14.8 (8.5–20.3) 22 (11.1–98.1) 0.110 median (IQR) Exitus, N (%) 9 (50.0) 4 (36.4) 6 (30.0) 0.491 10 (38.5) 14 (63.6) 6 (25.0) 0.027 Months of 35.2 (18.4–63.4) 129.8 (101.1– 59.1 (14.4– 0.001 28.3 (12.3–74.4) 63 (18.9–119.3) 23.6 (11.1– 0.174 follow- up, 151) 155.0) 100.8) median (IQR) P probability, BMI bodymassindex, PH parastomalhernia, IQR interquartilerange Fig. 1  Time-to-event analysis according end colostomy formation with and without the use of a prophylactic synthetic mesh: a overall study population, b laparoscopic modified Sugarbaker, c laparoscopic keyhole, d open retromuscular 13 Hernia (2023) 27:657–664 661 Fig. 2  Time-to-event analysis according to the surgical technique of mesh placement: a overall study population, b with mesh, c without mesh Among patients with PH, hernia repair was carried this discussion will refer preventing the development of out in: 4 (1 mesh and 3 non-mesh) of the 29 patients in PH formation in this context. We are aware that the global the modified Sugarbaker group (13.8%); 10 (4 mesh and evidence in favor of the use of a prophylactic mesh for the 6 non-mesh) of the 29 patients in the keyhole technique prevention of PH is not uniform regarding quality and risk (34.5%) and 5 (1 mesh and 4 non-mesh) of the 24 patients of bias (methodology, mesh placement technique, definition in the retromuscular technique (20.8%). and diagnosis of PH), and that surgeons cannot be equally confident in the results of all systematic reviews and meta- analyses published on this topic [6]. However, recent publi- Discussion cations of meta-analysis against [11] and in favor [12] of the efficacy of prophylactic mesh for PH prevention generates The present analysis of the efficacy of a synthetic mesh in confusion in clinical decision making. In our opinion, one the prevention of PH showed that mesh placement at the of the main concerns is the lack of long-term results. Short- time of end colostomy construction was not associated with term results (maximum at 1 or 2 years) are reported by all of a preventive effect in the long term, neither for the lapa- these meta-analyses. In our study, the overall median length roscopic approach using a modified Sugarbaker technique of follow-up until development of PH was 17.7 months or an intraperitoneal keyhole procedure, not for an open (IQR 9.3–49.0), which may indicate that probably a short- approach using a retromuscular insertion technique. A total term follow-up may not be the most appropriate time frame rate of PH of 67.8% is very discouraging. However, despite to assess the occurrence of PH after a prophylactic mesh. the lack of significant overall efficacy, the retromuscular In addition, the surgical procedures for mesh placement open technique showed the most favorable results. reported in the literature are heterogeneous, with the retro- It should be noted that the overwhelming majority of muscular technique and an open approach being the most information in the literature about the prevention of PH commonly used [5, 6, 11, 12]. with mesh refers to the use of permanent synthetic mesh in We agree with other authors that perhaps not all clinical patients undergoing permanent end colostomy in an elec- research on the prevention of PH with a mesh should be tive surgery setting [5, 6, 11, 12] and that all comments in limited to whether or not PH occurs [22]; probably it may 13 662 Hernia (2023) 27:657–664 be necessary to investigate other aspects related to PH as a prevention in terms of developing HP or not, and in this pathological condition far beyond its presence or absence. respect, it is interesting to consider the parallelism between Some aspects, such the impact of the various PH subtypes PH prevention and treatment. In the latter, data from the on the quality of life, the patient’s characteristics, or the literature in different registries (real-world evidence) show different types of stomas associated with PH may be consid- a very high recurrence rate in the short term [3] and high ered before performing any prophylactic intervention. Other probabilities of recurrence in the long term [25]. Both treat- aspects after the intervention may be considered, such as ment and prevention of PH may be palliative in the exclusive the influence of the type of mesh and its position, PH repair terms of developing PH or not. rates, or the importance of hernia repair in the context of Regarding the number of PH repairs following preventing a previous prophylactic mesh. However, these interesting attempts, it has been reported that placement of a prophy- quantitative and qualitative characteristics need to be evalu- lactic mesh reduces significantly the rates of hernia repairs ated in futures studies [22]. In our opinion, recommendation and is associated with a decrease of clinically significant of a non-absorbable synthetic prophylactic mesh in a patient PH rates [15, 22]. In the present analysis, the majority of requiring a permanent end colostomy should be currently repaired PH was also in the non-mesh group. However, the based on the consideration of the likelihood of development strength of these data is low and more studies will be needed of PH in the individual patient and the practice of a shared to clarify this “protective effect” of the mesh. Among other decision-making process. This process entails a relationship reasons, surgeons may be reluctant to perform reoperations of trust between patient and surgeon, where the surgeon in patients with a previous mesh due to potential techni- must recognize and respect the autonomy of the patient and cal difficulties. Also, registry data seem to indicate that the the patient must have reasonable knowledge of the problems cumulative incidence of recurrent PH repair at 5 years may related to the prevention of PH and the risk and benefits of be as low as 5% (95% CI 3% to 5%) [25]. Data of our study the different surgical options [23, 24]. showed variable rates of PH repair after prevention attempt Evidence of previous RCTs together with long-term data with percentages of 13.8%, 20.8%, and 34.5% according to provided by the analysis of the present study may be useful the technique used, but quite consistent with results reported during the shared decision-making process when a prophy- in the aforementioned registries, where the cumulative inci- lactic mesh is proposed for preventing a PH. In this respect, dence of a primary repair was 9% (95% CI 8% to 11%) we believe that the patient can be informed according to the within 1 year and 19% (95% CI 17% to 22%) within 5 years following considerations: (a) data in the literature refer only after the occurrence of a PH [25]. Therefore, it is probable to the risk of developing PH; (b) the final impact of the mesh that more robust evidence is needed to confirm the “protec- on the patient’s quality of life remains unclear whether in tive effect” of a prophylactic mesh, particularly as previ- the presence or absence of PH, as well as the most appropri- ously mentioned, taking into account how little is known ate mesh and its position, or which is the most appropriate of the impact of mesh on the patient's quality of life and patient to place the prophylactic mesh; (c) in the short term what occurs when a PH develops in a patient with a previous (< 2 years), a mesh seems to be effective using laparoscopic prophylactic mesh. techniques, although there are few studies using two differ- Limitations of the study are the relatively small number ent techniques (keyhole and modified Sugarbaker) and with of patients and the intrinsic heterogeneity of the analyses a small sample size [5, 12]; (d) in the short term (< 2 years), mainly the difference in mesh placement approach, however, the efficacy of a mesh using open retromuscular techniques all the patients presented the same underlying pathology, is controversial [5, 11, 12]; (e) in the long term (3 or more with the same prevention procedure (i.e. non-absorbable years), previous evidence of ineffectiveness of a mesh when synthetic prophylactic mesh) and identical endpoints after an a laparoscopic keyhole technique is used [15] or an open analysis of randomized parallel groups. Also, no patient was retromuscular technique is used [16] were also confirmed in clinically examined. Other characteristics, such as the effect our analysis, which also showed ineffectiveness of the modi- of mesh vs. non-mesh on the quality of life or PH repair in fied Sugarbaker technique; and (f) in the long term (3 years the context of a previous prophylactic mesh were not evalu- or more), a mesh seems effective in two studies in which an ated. Strengths of the study include the fact that radiological open retromuscular technique was used [13, 14]. According diagnosis of PH was blinded for the different study groups. to the present findings, the use of a mesh in this context does In summary, the effectiveness of a non-absorbable pro- not appear to be effective, although the retromuscular posi- phylactic mesh in the context of an elective permanent tion would be the most appropriate for the prevention of PH end colostomy for preventing PH in the long term remains as compared with the laparoscopic techniques. unproven. Even so the technique that performed best in In these circumstances, it is very difficult to solve the terms of prevention was the retromuscular procedure and question of whether a prophylactic mesh should be used or the worst the keyhole technique. The “protective effect” not. It may be argued that it is finally a question of palliative of a prophylactic mesh in terms of reducing the rates of 13 Hernia (2023) 27:657–664 663 interventions or clinically significant PH remains to be References elucidated. Placement of a mesh for the prevention of PH in terms of appearance vs. non-appearance of a PH shows 1. Temple B, Farley T, Popik K, Ewanyshyn C, Beyer E, Dufault that the incidences of PH are high and perhaps going even B (2016) Prevalence of parastomal hernia and factors associ- ated with its development. J Wound Ostomy Continence Nurs higher with longer follow-up. In the previous context, PH 43:489–493 prevention with permanent mesh in end colostomy is at best 2. van Dijk SM, Timmermans L, Deerenberg EB, Lamme B, Klein- considered a delaying strategy. rensink GJ, Jeekel J et al (2015) Parastomal hernia: impact on quality of life? World J Surg 39:2595–2601 Acknowledgements The authors thank Sergi Mojal, biostatistician, for 3. López-Cano M, Pereira JA, Rodrigues-Gonçalves V, Verdaguer- his contribution in the statistical analysis, and Marta Pulido, MD, for Tremolosa M, Hernández-Granados P, Bravo-Salvá A, EVEREG editing the manuscript and editorial assistance. Registry (2021) Parastomal hernia repair. Prospective observa- tional study based on the Spanish Registry of Incisional Hernia Author contributions MLC and MAT: conception and design, review (EVEREG). Cir Esp (Engl Ed) 99:527–534 of the literature, statistical analysis. MLC: writing of the manuscript, 4. Mäkäräinen-Uhlbäck E, Vironen J, Falenius V, Nordström P, general supervision of the study. MVT, VRG and JBC: review of the Välikoski A, Kössi J et al (2021) Parastomal hernia: a retrospec- medical records, critical review of the draft for intellectual content. tive nationwide cohort study comparing different techniques XSA: conception and design, general supervision of the analysis, criti- with long-term follow-up. World J Surg 45:1742–1749 cal review for intellectual content. All authors have seen and approved 5. López-Cano M, Brandsma HT, Bury K, Hansson B, Kyle-Lein- the final draft. hase I, Alamino JG et al (2017) Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial Funding Open Access Funding provided by Universitat Autonoma de sequential analysis. Hernia 21:177–189 Barcelona. No direct or indirect financial support by extramural sources 6. García-Alamino JM, López-Cano M, Kroese L, Helgstrand F, was received. Muysoms F (2019) Quality assessment and risk of bias of system- atic reviews of prophylactic mesh for parastomal hernia prevention Data availability The study data are available from the corresponding using AMSTAR and ROBIS tools. World J Surg 43:3003–3012 author upon request. 7. Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT et al (2018) European Hernia Society guide- Declarations lines on prevention and treatment of parastomal hernias. Hernia 22:183–198 Conflict of interest M. López-Cano has received honoraria for consul- 8. Odensten C, Strigård K, Rutegård J, Dahlberg M, Ståhle U, Gun- tancy, lectures, support for travels and participation in review activities narsson U et al (2019) Use of prophylactic mesh when creating from BD, Medtronic and Gore and is a member of the Board of the a colostomy does not prevent parastomal hernia: a randomized European Hernia Society (unpaid). All other authors have no conflict controlled trial-STOMAMESH. Ann Surg 269:427–431 of interest to disclose. 9. Prudhomme M, Rullier E, Lakkis Z, Cotte E, Panis Y, Meunier B et al (2021) End colostomy with or without mesh to prevent Ethical approval The study design, the surgical procedure, and approval a parastomal hernia (GRECCAR 7): a prospective, randomized, by the institutional review board of the three trials were reported in the double blinded, multicentre trial. Ann Surg 274:928–934 corresponding publications of short-term results. Patients included in 10. Correa Marinez A, Bock D, Erestam S, Engström A, Kälebo P, the three trials were initially informed of the possibility of participat- Nielsen YW et al (2021) Methods of colostomy construction: no ing in a retrospective study aimed to collect long-term follow-up data. effect on parastomal hernia rate: results from Stoma-const-A ran- domized controlled trial. Ann Surg 273:640–647 Informed consent Patients were requested to sign the written informed 11. Prudhomme M, Fabbro-Peray P, Rullier E, Occean BV, Bertrand consent. MM (2021) Meta-analysis and systematic review of the use of a prosthetic mesh for prevention of parastomal hernia. Ann Surg Human and animal rights This article does not contain any study with 274:20–28 animals performed by any of the authors. 12. McKechnie T, Lee J, Lee Y, Doumouras A, Amin N, Hong D, Eskicioglu C (2022) Prophylactic mesh for prevention of paras- tomal hernia following end colostomy: an updated systematic Open Access This article is licensed under a Creative Commons Attri- review and meta-analysis of randomized controlled trials. J Gas- bution 4.0 International License, which permits use, sharing, adapta- trointest Surg 26:486–502 tion, distribution and reproduction in any medium or format, as long 13. Jänes A, Cengiz Y, Israelsson LA (2009) Preventing parastomal as you give appropriate credit to the original author(s) and the source, hernia with a prosthetic mesh: a 5-year follow-up of a randomized provide a link to the Creative Commons licence, and indicate if changes study. World J Surg 33:118–121 were made. The images or other third party material in this article are 14. Lambrecht JR, Larsen SG, Reiertsen O, Vaktskjold A, Julsrud L, included in the article's Creative Commons licence, unless indicated Flatmark K (2015) Prophylactic mesh at end-colostomy construc- otherwise in a credit line to the material. If material is not included in tion reduces parastomal hernia rate: a randomized trial. Colorectal the article's Creative Commons licence and your intended use is not Dis 17:O191-197 permitted by statutory regulation or exceeds the permitted use, you will 15. Mäkäräinen-Uhlbäck EJ, Klintrup KHB, Vierimaa MT, Carpelan- need to obtain permission directly from the copyright holder. To view a Holmström MA, Kössi JAO, Kairaluoma MV et al (2020) Pro- copy of this licence, visit http://​creat​iveco​mmons.​org/​licen​ses/​by/4.​0/. spective, randomized study on the use of prosthetic mesh to pre- vent a parastomal hernia in a permanent colostomy: Results of a long-term follow-up. Dis Colon Rectum 63:678–684 16. Ringblom C, Odensten C, Stringard K, Gunnarsson U, Näsvall P (2023) No reduction in paraestomal hernia rate 3 years after 13 664 Hernia (2023) 27:657–664 stoma construction with prophylactic mesh: three-year follow-up. modalities for the diagnosis of parastomal hernia: a systematic Results from STOMAMESH—a multicenter double-blind rand- review. Int J Colorectal Dis 35:199–212 omized controlled trial. Ann Surg 277:38–42 22. Rajaretnam N, Smart NJ (2021) To mesh or not to mesh-the 17. Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, known unknowns of preventing parastomal hernias. Br J Surg Mora-Lopez L, Alcantara-Moral M et al (2009) Randomized, con- 17:1–2 trolled, prospective trial of the use of a mesh to prevent parastomal 23. de Mik SML, Stubenrouch FE, Balm R, Ubbink DT (2018) Sys- hernia. Ann Surg 249:583–587 tematic review of shared decision-making in surgery. Br J Surg 18. López-Cano M, Lozoya-Trujillo R, Quiroga S, Sánchez JL, Vall- 105:1721–1730 ribera F, Martí M et al (2012) Use of a prosthetic mesh to prevent 24. Pieterse AH, Stiggelbout AM, Montori VM (2019) Shared deci- parastomal hernia during laparoscopic abdominoperineal resec- sion making and the importance of time. JAMA 322:25–26 tion: a randomized controlled trial. Hernia 16:661–667 25. Krogsgaard M, Gögenur I, Helgstrand F, Andersen RM, Danielsen 19. López-Cano M, Serra-Aracil X, Mora L, Sánchez-García JL, AK, Vinther A et al (2020) Surgical repair of parastomal bulg- Jiménez-Gómez LM, Martí M et al (2016) Preventing parasto- ing: a retrospective register-based study on prospectively collected mal hernia using a modified sugarbaker technique with composite data. Colorectal Dis 22:1704–1713 mesh during laparoscopic abdominoperineal resection: a rand- omized controlled trial. Ann Surg 264:923–928 Publisher's Note Springer Nature remains neutral with regard to 20. Gurmu A, Matthiessen P, Nilsson S, Påhlman L, Rutegård J, jurisdictional claims in published maps and institutional affiliations. Gunnarsson U (2011) The inter-observer reliability is very low at clinical examination of parastomal hernia. Int J Colorectal Dis 26:89–95 21. de Smet GHJ, Lambrichts DPV, van den Hoek S, Kroese LF, Buettner S, Menon AG et al (2020) Comparison of different 13