Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Gothenburg, Sweden.
Region Västra Götaland, Sahlgrenska University Hospital/Östra, Department of Surgery, Gothenburg, Sweden.
Ann Surg. 2021 Apr 1;273(4):640-647. doi: 10.1097/SLA.0000000000003843.
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.
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%.
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.
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.
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.
本试验的主要目的是比较 3 种外科技术(横切口、筋膜环行切口和预防性使用补片)在造口术后 1 年时的造口旁疝发生率。次要目标是评估术后并发症、再入院/再手术率以及造口旁疝的风险因素。
造口术的构建技术已经被探索过,目的是改善功能并减少造口并发症,但造口旁疝的发生较为频繁,发病率约为 50%。
在瑞典和丹麦的 3 家医院进行了一项随机、多中心试验;所有计划接受末端造口术的患者均被要求参与。通过腹部 CT 检查(俯卧位)和临床评估来确定 12 个月内发生的造口旁疝。还评估了并发症、再入院、再手术以及风险因素。
209 例患者被随机分为 3 个研究组。3 组患者的人口统计学特征相似。185 例患者可进行造口旁疝评估。造口旁疝的风险比(95%置信区间)为 1.25(0.83;1.88),横切口与环行组和横切口与补片组分别为 1.22(0.81;1.84)。3 组间造口旁疝发生率无统计学差异。年龄和体重指数与造口旁疝的发生有关。
我们发现 3 种造口术构建技术在指数手术后 12 个月内的造口旁疝发生率没有显著差异。