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Reinforced tension-line suture after laparotomy: early results of the Rein4CeTo1 randomized clinical trial.
British Journal of Surgery ( IF 8.6 ) Pub Date : 2024-09-03 , DOI: 10.1093/bjs/znae265
Charlotta L Wenzelberg,Peder Rogmark,Olle Ekberg,Ulf Petersson

BACKGROUND The aim was to investigate whether adding a reinforced tension-line (RTL) suture to a standard 4 : 1 small-bite closure would reduce the incidence of incisional hernia after colorectal cancer surgery. METHODS Patients aged at least 18 years, who were scheduled for elective colorectal cancer surgery through a midline incision at two Swedish hospitals (2017-2021), were randomized in a 1 : 1 ratio to either fascial closure with RTL and 4 : 1 small-bite closure with polypropylene sutures (RTL group) or 4 : 1 small-bite closure with polydioxanone suture alone (PDS group). The primary outcome was CT-detected incisional hernia 1 year after surgery. CT interpreters were blinded regarding treatment group. RESULTS In all, 160 patients were randomized, 80 in each group. The study closed early to recruitment and follow-up. Some 134 patients were analysed at 1 year: 63 in the RTL group and 71 in the PDS group. Nineteen patients were found to have an incisional hernia: 4 (6%) in the RTL group and 15 (21%) in the PDS group (OR 3.95, 95% c.i. 1.24 to 12.60; P = 0.014). No unintended effects were found in either group. CONCLUSION Adding an RTL suture at fascial closure decreased the incidence of incisional hernia in patients undergoing surgery for colorectal cancer. Trial registration: NCT03390764 (https://clinicaltrials.gov).

中文翻译:


剖腹手术后加强张力线缝合:Rein4CeTo1 随机临床试验的早期结果。



背景 目的是研究在标准的 4 : 1 小咬合缝合上添加加强张力线 (RTL) 缝合是否会降低结直肠癌手术后切口疝的发生率。方法 2017-2021 年在瑞典两家医院(2017-2021 年)计划通过中线切口进行择期结直肠癌手术的至少 18 岁患者以 1:1 的比例随机分配到 RTL 筋膜闭合和 4:1 聚丙烯缝合小咬合闭合(RTL 组)或 4:1 小咬合闭合单独聚二恶烷酮缝合(PDS 组)。主要结局是术后 1 年 CT 检测到的切口疝。CT 解释者对治疗组不知情。结果 总共随机分配 160 例患者,每组 80 例。该研究在招募和随访之前提前结束。在 1 年时分析了约 134 例患者: RTL 组 63 例,PDS 组 71 例。发现 19 例患者患有切口疝:RTL 组 4 例 (6%),PDS 组 15 例 (21%) (OR 3.95,95% CI 1.24 至 12.60;P = 0.014)。两组均未发现意外影响。结论 在筋膜闭合处加用 RTL 缝合线可降低结直肠癌手术患者切口疝的发生率。试用注册:NCT03390764 (https://clinicaltrials.gov)。
更新日期:2024-09-03
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