Evidence map›Paper›PMID 36855158›Full record

ArticleTrials2023

Impact of non-muscle cutting periumbilical transverse incision on the risk of incisional hernia as compared to midline incision during laparoscopic colon cancer surgery: a study protocol for a multi-centre randomised controlled trial.

Soo Yeun Park, Gi Won Ha, Soo Young Lee, Chang Hyun Kim, Gyung Mo Son

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 22% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

5 authors at 4 institutions in 1 country.

Soo Yeun ParkColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
Gi Won HaResearch Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.
Soo Young LeeDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun, South Korea.
Chang Hyun KimDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun, South Korea. cksantiago8@gmail.com.ORCID http://orcid.org/0000-0002-1954-189X
Gyung Mo SonDepartment of Surgery, Pusan National University Yangsan Hospital, School of Medicine, Pusan National University, Yangsan, Republic of Korea.
Chonnam National University Hwasun Hospital · KRJeonbuk National University Hospital · KRKyungpook National University Hospital · KRPusan National University Yangsan Hospital · KR

Funding

Chonnam National University Hwasun Hospital a grant (HCRI 21027) Chonnam National University Hwasun Hospital Institute of Biomedical Science
6 · The paper itself

Abstract

backgroundMinimally invasive surgery has become popular as a surgical approach for colorectal cancer because it has fewer complications related to the abdominal incision and perioperative complications. However, the incidence of incisional hernias in laparoscopic surgery has been reported to be similar to that in open surgery. We developed a new method, the non-muscle-cutting periumbilical transverse incision, for a small incision in laparoscopic colon cancer surgery. This study aims to evaluate the effectiveness of the non-muscle-cutting periumbilical transverse incision in comparison with the midline incision in reducing the incidence of an incisional hernia in patients undergoing laparoscopic colon cancer surgery.

methodsThis is an open-label, multi-centre, parallel, superiority, and randomised trial. Altogether, 174 patients will be allocated in a 1:1 ratio to either the midline incision or the non-muscle-cutting periumbilical transverse incision group, after stratifying by the location of the tumour (right- or left-sided). The primary outcome of this study is the incidence of incisional hernias (both symptomatic and radiologic hernias) at 12 months after surgery. The secondary outcomes include operative outcomes, 30-day postoperative complications, pathological results, and patient-reported outcomes (short form-12 health survey questionnaire and body image questionnaire). Both primary (intention-to-treat) and secondary (as-treated principles) analyses will be performed for all outcomes. The statistical significance level was set at p < 0.05 (two-sided testing). DISCUSSION: This trial may show that the non-muscle-cutting periumbilical transverse incision will reduce the incidence of incisional hernias compared to the midline incision.

trial registrationClinical Research Information Service (CRiS) of Republic of Korea, KCT0006082 . Registered on April 12, 2021.

Indexed as

Colonic NeoplasmsIncisional HerniaBody ImageEquivalence Trials as TopicHealth SurveysHumansMulticenter Studies as TopicPostoperative ComplicationsRandomized Controlled Trials as TopicIncisional herniaLaparoscopesLaparotomyProtocolRCTWounds and injuries

Identifiers

PMID36855158
PMCPMC9976431
OpenAlexW4322625233

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.