经腹正中切口关闭术以减少择期胃肠外科手术后切口并发症发生率的理想方法的开发：一项随机对照试验的研究方案。

Superiority trial for the development of an ideal method for the closure of midline abdominal wall incisions to reduce the incidence of wound complications after elective gastroenterological surgery: study protocol for a randomized controlled trial.

机构信息

Department of Surgery, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma-Cho, Omiya-Ku, Saitama, 330-8503, Japan.

出版信息

Trials. 2024 May 17;25(1):327. doi: 10.1186/s13063-024-08167-w.

DOI:10.1186/s13063-024-08167-w

PMID:38760769

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11100179/

Abstract

BACKGROUND

The recent guidelines from the European and American Hernia Societies recommend a continuous small-bite suturing technique with slowly absorbable sutures for fascial closure of midline abdominal wall incisions to reduce the incidence of wound complications, especially for incisional hernia. However, this is based on low-certainty evidence. We could not find any recommendations for skin closure. The wound closure technique is an important determinant of the risk of wound complications, and a comprehensive approach to prevent wound complications should be developed.

METHODS

We propose a single-institute, prospective, randomized, blinded-endpoint trial to assess the superiority of the combination of continuous suturing of the fascia without peritoneal closure and continuous suturing of the subcuticular tissue (study group) over that of interrupted suturing of the fascia together with the peritoneum and interrupted suturing of the subcuticular tissue (control group) for reducing the incidence of midline abdominal wall incision wound complications after elective gastroenterological surgery with a clean-contaminated wound. Permuted-block randomization with an allocation ratio of 1:1 and blocking will be used. We hypothesize that the study group will show a 50% reduction in the incidence of wound complications. The target number of cases is set at 284. The primary outcome is the incidence of wound complications, including incisional surgical site infection, hemorrhage, seroma, wound dehiscence within 30 days after surgery, and incisional hernia at approximately 1 year after surgery.

DISCUSSION

This trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates.

TRIAL REGISTRATION

UMIN-CTR UMIN000048442. Registered on 1 August 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205.

摘要

背景

欧美疝学会最近的指南建议采用连续小切口缝合技术，使用可缓慢吸收缝线缝合筋膜，以减少中线腹壁切口的并发症发生率，特别是切口疝。然而，这是基于低确定性证据。我们没有找到任何关于皮肤缝合的建议。伤口闭合技术是伤口并发症风险的重要决定因素，应制定综合方法预防伤口并发症。

方法

我们提出了一项单中心、前瞻性、随机、盲终点试验，以评估连续缝合筋膜而不缝合腹膜与连续缝合皮下组织的组合（研究组）与间断缝合筋膜加腹膜和间断缝合皮下组织（对照组）在降低择期胃肠外科手术中清洁污染伤口中线腹壁切口并发症发生率方面的优势。采用区组随机化，分配比为 1:1，且区组大小为 4。我们假设研究组的伤口并发症发生率将降低 50%。目标病例数设定为 284 例。主要结局是伤口并发症的发生率，包括切口手术部位感染、出血、血清肿、术后 30 天内切口裂开和术后约 1 年切口疝。