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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Rectal Cancer | Study protocol

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

Authors: Soo Young Lee, Sohyun Kim, Gyung Mo Son, Hye Jin Kim, Soo Yeun Park, Jun Seok Park, Chang Hyun Kim, Gi Won Ha, Kyung-Ha Lee, Jin Soo Kim, Ki Beom Bae, Sung Uk Bae, Sung Il Kang, Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS)

Published in: Trials | Issue 1/2022

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Abstract

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 α 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.

Trial registration

Clinical Research Information Service KCT0003523. Registered on February 18, 2019
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Soo Young Lee
Sohyun Kim
Gyung Mo Son
Hye Jin Kim
Soo Yeun Park
Jun Seok Park
Chang Hyun Kim
Gi Won Ha
Kyung-Ha Lee
Jin Soo Kim
Ki Beom Bae
Sung Uk Bae
Sung Il Kang
Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS)
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06862-0

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