Annals of Surgery · 2016 · 93 citations · 17 references
MedicineOncologySurgeryGeneral SurgeryOncologic SurgerySurgical OncologyAbdominal SurgeryColorectal SurgeryGastrointestinal Cancer SurgeryHernia RepairHernia SurgeryLaparoscopic SurgeryAbdominal Wall Hernia RepairLaparoscopic Cancer SurgeryLaparoscopic ResectionParastomal Hernia ManagementParastomal Hernia RepairPostoperative Abdominal ComplicationsRectal Cancer SurgerySynthetic Mesh Use
OBJECTIVE: The aim of this study was to assess the reduction in the incidence of parastomal hernia (PH) after placement of prophylactic synthetic mesh using a modified Sugarbaker technique when a permanent end-colostomy is needed. SUMMARY OF BACKGROUND DATA: Prevention of PH formation is crucial given the high prevalence of PH and difficulties in the surgical repair of PH. METHODS: A randomized, prospective, double-blind, and controlled trial. Rectal cancer patients undergoing laparoscopic abdominoperineal resection with permanent colostomy were randomized (1 : 1) to the mesh and nonmesh arms. In the mesh group, a large-pore lightweight composite mesh was placed in the intraperitoneal/onlay fashion using a modified Sugarbaker technique. PH was detected by computed tomography (CT) after a minimum follow-up of 12 months. Analysis was per-protocol. RESULTS: The mesh group included 24 patients and the control group 28. Preoperative data, surgical time, and postoperative morbidity were similar. The median follow-up was 26 months. After CT examination, 6 of 24 PHs (25%) were observed in the mesh group compared with 18 of 28 (64.3%) in the nonmesh group (odds ratio 0.39, 95% confidence interval 0.18-0.82; P = 0.005). The Kaplan-Meier curves showed significant differences in favor of the mesh group (long-rank = 4.21, P = 0.04). The number needed to treat was 2.5, which confirmed the effectiveness of the intervention. CONCLUSIONS: Placement of a prosthetic mesh by the laparoscopic approach following the modified Sugarbaker technique is safe and effective in the prevention of PH, reducing significantly the incidence of PH.
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The number needed to treat: a clinically useful measure of treatment effect
Richard J. Cook, D L Sackett · BMJ · 1995 · 1.9K citations