可吸收带刺缝线用于结直肠和胃癌微创手术中正中筋膜闭合对切口疝的影响：一项随机对照试验的研究方案。

The effect on incisional hernia of absorbable barbed suture for midline fascial closure in minimally invasive surgery for colorectal and gastric cancers: study protocol for a randomized controlled trial.

机构信息

Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Republic of Korea.

Department of Surgery, Jeonbuk National University Hospital, 20 Geonji-Ro, Deokjin-Gu, Jeonju, 54907, Republic of Korea.

出版信息

Trials. 2023 May 6;24(1):311. doi: 10.1186/s13063-023-07324-x.

DOI:10.1186/s13063-023-07324-x

PMID:37149610

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10164296/

Abstract

BACKGROUND

Incisional hernia following abdominal surgery is a frequent complication of midline laparotomy. This complication is strongly associated with the technique and material used for suture. While a monofilament absorbable suture is recommended to prevent incisional hernia, it can lead to suture loosening or surgical-knot breakage. Although barbed sutures can be an alternative suture material in abdominal fascial closure, evidence for its safety and effectiveness is lacking. Therefore, we designed a prospective randomized trial to evaluate the safety and efficacy of absorbable barbed sutures for midline fascia closure in minimally invasive surgery for colorectal and gastric cancers in comparison with conventional absorbable monofilament sutures.

METHODS

A total of 312 patients who underwent minimally invasive surgery for colorectal and gastric cancers will be randomly allocated to either the absorbable barbed or monofilament suture group for abdominal fascia closure in a 1:1 ratio. The primary outcome is incisional hernia rate within 3 years after surgery, as verified by physical examination and computed tomography. Postoperative complications, including surgical site infection, postoperative pain, and quality of life, will be compared between two groups as secondary outcomes. The investigator will examine the patients until discharge and at 6, 12, 18, 24, and 36 months postoperatively.

DISCUSSION

This is the first randomized controlled trial to compare absorbable barbed sutures with monofilament sutures for midline fascia closure in minimally invasive surgery. If absorbable barbed sutures demonstrate superior results to those of monofilament sutures, this type of suture material may be recommended as an alternative option for abdominal fascia closure.

TRIAL REGISTRATION

KCT0007069. Registered on January 30, 2023.

摘要

背景

腹部手术后切口疝是中线剖腹手术的常见并发症。这种并发症与缝线的技术和材料密切相关。虽然推荐使用单丝可吸收缝线来预防切口疝，但它可能导致缝线松动或手术结断裂。虽然带倒刺缝线可作为腹部筋膜缝合的替代缝线材料，但缺乏其安全性和有效性的证据。因此，我们设计了一项前瞻性随机试验，以评估可吸收带倒刺缝线与传统可吸收单丝缝线在微创结直肠和胃癌手术中用于中线筋膜缝合的安全性和有效性。

方法

共有 312 例接受微创结直肠和胃癌手术的患者将以 1:1 的比例随机分配到可吸收带倒刺缝线或单丝缝线组进行腹部筋膜缝合。主要结局是术后 3 年内切口疝发生率，通过体格检查和计算机断层扫描证实。将两组之间的术后并发症（包括手术部位感染、术后疼痛和生活质量）作为次要结局进行比较。调查员将在患者出院后以及术后 6、12、18、24 和 36 个月进行检查。