Evidence map›Paper›PMID 36316694›Full record

ArticleTrials2022

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.

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 and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 52% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 1 country.

Soo Young Lee *Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun, Jeonnam, South Korea.
Sohyun Kim *Department of Surgery, College of Medicine, Yeungnam University, Daegu, South Korea.
Gyung Mo SonDepartment of Surgery, Pusan National University Yangsan Hospital, School of Medicine, Pusan National University, 20 Geumo-ro Mulgeum-eup, Yangsan, 50612, South Korea. skm1711@pusan.ac.kr.ORCID http://orcid.org/0000-0002-8861-6293
Hye Jin KimColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 40414, South Korea. hjinkim@knu.ac.kr.
Soo Yeun ParkColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 40414, South Korea.
Jun Seok ParkColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 40414, South Korea.
Chang Hyun KimDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun, Jeonnam, South Korea.
Gi Won HaResearch Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Jeonbuk, South Korea.
Kyung-Ha LeeDepartment of Surgery, Chungnam National University Hospital & College of Medicine, Chungnam National University, Daejeon, South Korea.
Jin Soo KimDepartment of Surgery, Chungnam National University Sejong Hospital & College of Medicine, Chungnam National University, Daejeon, South Korea.
Ki Beom BaeDepartment of Surgery, Paik Institute for Clinical Research, Inje University, College of Medicine, Inje University, Busan Paik Hospital, Busan, South Korea.
Sung Uk BaeDepartment of Surgery, School of Medicine, Keimyung University and Dongsan Medical Center, Daegu, South Korea.
Sung Il KangDepartment of Surgery, College of Medicine, Yeungnam University, Daegu, South Korea.
Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS)
Kyungpook National University Hospital · KRChonnam National University Hwasun Hospital · KRChungnam National University Hospital · KRYeungnam University · KRInje University Busan Paik Hospital · KRJeonbuk National University Hospital · KRKeimyung University Dongsan Medical Center · KRPusan National University Yangsan Hospital · KR

Funding

Medtronic Korea ERP-2018-11315National Research Foundation of Korea 2021R1A5A2021614
6 · The paper itself

Abstract

backgroundAlthough 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/

designPatients 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 registrationClinical Research Information Service KCT0003523. Registered on February 18, 2019.

Indexed as

Anastomotic LeakRectal NeoplasmsHumansLigationMesenteric Artery, InferiorMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAnastomotic leakInferior mesenteric artery ligationRandomized controlled trialRectal cancer

Identifiers

PMID36316694
PMCPMC9620593
OpenAlexW4307687419

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.