Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial

被引：0

作者：

Lee, Soo Young ^{[1
,2
]}

Kim, Sohyun ^{[3
]}

Son, Gyung Mo ^{[4
]}

Kim, Hye Jin ^{[5
]}

Park, Soo Yeun ^{[5
]}

Park, Jun Seok ^{[5
]}

Kim, Chang Hyun ^{[1
,2
]}

Ha, Gi Won ^{[6
]}

Lee, Kyung-Ha ^{[7
,8
]}

Kim, Jin Soo ^{[8
,9
]}

Bae, Ki Beom ^{[10
]}

Bae, Sung Uk ^{[11
,12
]}

Kang, Sung Il ^{[3
]}

机构：

[1] Chonnam Natl Univ, Hwasun Hosp, Dept Surg, Hwasun, Jeonnam, South Korea

[2] Med Sch, Hwasun, Jeonnam, South Korea

[3] Yeungnam Univ, Coll Med, Dept Surg, Daegu, South Korea

[4] Pusan Natl Univ, Yangsan Hosp, Sch Med, Dept Surg, 20 Geumo Ro Mulgeum Eup, Yangsan 50612, South Korea

[5] Kyungpook Natl Univ, Chilgok Hosp, Colorectal Canc Ctr, Sch Med, 807 Hogukro, Daegu 40414, South Korea

[6] Jeonbuk Natl Univ, Jeonbuk Natl Univ Hosp, Biomed Res Inst, Res Inst Clin Med, Jeonju, Jeonbuk, South Korea

[7] Chungnam Natl Univ, Dept Surg, Chungnam Natl Univ Hosp, Daejeon, South Korea

[8] Chungnam Natl Univ, Coll Med, Daejeon, South Korea

[9] Chungnam Natl Univ, Sejong Hosp, Dept Surg, Daejeon, South Korea

[10] Inje Univ, Dept Surg, Busan Paik Hosp, Coll Med,Paik Inst Clin Res, Busan, South Korea

[11] Keimyung Univ, Sch Med, Dept Surg, Daegu, South Korea

[12] Dongsan Med Ctr, Daegu, South Korea

来源：

TRIALS | 2022年 / 23卷 / 01期

基金：

新加坡国家研究基金会;

关键词：

Rectal cancer; Anastomotic leak; Inferior mesenteric artery ligation; Randomized controlled trial; INDEX; PRESERVATION; INSTRUMENT; EXCISION; OUTCOMES; SURGERY;

D O I：

10.1186/s13063-022-06862-0

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background Although many efforts have been made to decrease the incidence of anastomotic leak (AL), it remains one of the most serious complications of rectal cancer surgery. Many previous studies have reported an association between the ligation level of the inferior mesenteric artery (IMA) (high or low) and the incidence of AL after rectal cancer surgery. However, we cannot draw a solid conclusion because of the low quality and heterogeneity of those studies. Therefore, this study aims to investigate the impact of the IMA ligation level on the occurrence of AL after minimally invasive anterior resection of rectal cancer. Methods/design Patients with primary rectal cancer without distant metastases will be included after screening. They will be randomly assigned (1:1) to receive high or low ligation of the IMA. The primary endpoint is AL incidence; secondary endpoints are quality of life; urinary, sexual, and defecatory functions; and 3-year disease-free survival. We hypothesized that the incidence rate of AL would be 15% and 5% in the high- and low-ligation groups, respectively. With a two-sided alpha of 0.05 and a power of 0.8, the sample size is calculated to be 314 patients (157 per group), considering a 10% dropout rate. Discussion Although many studies have compared the short- and long-term outcomes of high and low ligation of the IMA in rectal cancer surgery, it is still debatable. This trial aims to help draw a more solid conclusion regarding the association between the IMA ligation level and AL incidence after rectal cancer surgery. We also hope to contribute to standardizing the method of rectal cancer surgery in this trial.

引用

页数：7

共 29 条

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