ImportanceProphylactic placement of a mesh has been suggested to prevent parastomal hernia. Evidence to support this practice is contradictory.ObjectiveTo determine whether funnel-shaped permanent synthetic parastomal mesh is effective and safe in parastomal hernia prevention.Design, Setting, and ParticipantsThe Chimney Trial was a randomized single-blinded multicenter trial conducted in 4 hospitals in Finland and 1 in Sweden from February 2019 and September 2021. Of 439 patients with rectal adenocarcinoma undergoing either laparoscopic or robotic-assisted abdominoperineal resection or the Hartmann procedure, 143 were enrolled in the trial, 135 received their allocated intervention, and 121 were analyzed at 12-month follow-up. Data were analyzed from December 2023 to May 2024.InterventionIn the intervention group, a permanent colostomy was created with a funnel-shaped intraperitoneal mesh and compared to a control group with a stoma without the mesh.Main Outcome and MeasureThe primary end point was the incidence of computed tomography (CT)–confirmed parastomal hernia 12 months after surgery.ResultsThere were 68 patients (mean [SD] age, 68.7 [11.6] years; 36 [53% male and 32 [47%] female) who received the intended allocation in the mesh group and 67 (mean [SD] age, 66.4 [11.7] years; 48 [72%] male and 19 [28%] female) who received the intended allocation in the control group. CT scans were available for 58 patients in the mesh group and 59 patients in the control group at the 12-month follow-up. CT scans confirmed parastomal hernia in 6 of 58 patients (10%) in the mesh group compared to 22 of 59 patients (37%) in the control group (difference, 27%; 95% CI, 12-41; P < .001). Clinical parastomal hernia as a secondary outcome was recorded in 1 of 60 patients (2%) in the mesh group compared to 27 of 61 (43%) in the control group (difference, 41%; 95% CI, 29-55; P < .001). The number of patients with Clavien-Dindo class II ileus was 23 (35%) in the mesh group compared to 11 (17%) in the control group (difference, 18%; 95% CI, 3-32; P = .006). Only slight differences between the groups were detected in other stoma-related complications, readmissions, operative time, surgical site infections, reoperations, and quality of life.Conclusions and RelevanceIn this study, funnel-shaped parastomal mesh prevented a significant number of parastomal hernias without predisposing patients to mesh- or stoma-related complications during 12-month follow-up. The results of this study suggest the funnel-shaped mesh is a feasible option to prevent parastomal hernia.Trial RegistrationClinicalTrials.gov Identifier: NCT03799939

中文翻译：

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使用漏斗形腹腔内网片预防造口旁疝与无网片的比较


重要性建议预防性放置网片以预防造口旁疝。支持这种做法的证据是矛盾的。目的确定漏斗状永久性合成造口旁网片预防造口旁疝是否有效、安全。设计、设置和参与者Chimney 试验是一项随机、单盲、多中心试验，于 2019 年 2 月和 2021 年 9 月在芬兰的 4 家医院和瑞典的 1 家医院进行。在 439 例接受腹腔镜或机器人辅助腹会阴切除术或 Hartmann 手术的直肠腺癌患者中，143 例被纳入试验，135 例接受了分配的干预，121 例在 12 个月的随访中进行了分析。干预在干预组中，使用漏斗状腹膜内网创建永久性结肠造口术，并与没有网片的造口对照组进行比较。主要结局和测量主要终点是术后 12 个月经计算机断层扫描 （CT） 证实的造口旁疝的发生率。结果有 68 例患者 （平均 [SD] 年龄，68.7 [11.6] 岁;36 例 [53% 男性和 32 [47%] 女性）在网状组中接受了预期分配，67 例 （平均 [SD] 年龄，66.4 [11.7] 岁;48 [72%] 男性和 19 例 [28%] 女性）在对照组接受了预期分配。在 12 个月的随访中，网片组 58 例患者和对照组 59 例患者可进行 CT 扫描。CT 扫描证实网片组 58 例患者中有 6 例 （10%） 存在造口旁疝，而对照组 59 例患者中有 22 例 （37%） （差异，27%;95% CI，12-41;P < .001）。 补片组 60 例患者中有 1 例 （2%） 记录了临床造口旁疝作为次要结局，而对照组 61 例患者中有 27 例 （43%） 记录（差异，41%;95% CI，29-55;P < .001）。网状组 Clavien-Dindo II 级肠梗阻患者人数为 23 例 （35%），而对照组为 11 例 （17%） （差异，18%;95% CI，3-32;P = .006）。在其他造口相关并发症、再入院、手术时间、手术部位感染、再次手术和生活质量方面，仅检测到组间微小差异。结论和相关性在这项研究中，漏斗状造口旁网片预防了大量造口旁疝，在 12 个月的随访期间，患者没有易患网片或造口相关并发症。这项研究的结果表明，漏斗形网片是预防造口旁疝的可行选择。试验注册临床试验。gov 标识符： NCT03799939