Evidence map›Paper›PMID 35799145›Full record

ArticleBMC cancer2022

Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial.

Zijia Song, Kun Liu, Tao Zhang, Bingshun Wang, Yiqing Shi, Yimei Jiang, Changgang Wang, Xianze Chen, Xiaopin Ji, Ren Zhao

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04527861 (Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT04527861 narecruitingnot on this map

Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

TypeinterventionalSponsorRuijin HospitalRan2021 to 2029Enrolled710ConditionsColorectal Cancer, Colon Cancer, Rectal CancerArmsSingle-incision Laparoscopic Surgery, Conventional Laparoscopic Surgery
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  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

10 authors at 1 institution in 1 country.

Zijia Song *Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Kun Liu *Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Tao Zhang *Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Bingshun WangDepartment of Biostatistics and Clinical Research Center, Shanghai Jiao Tong University School of Medicine, No. 227, South Chongqing Road, Huangpu District, Shanghai, 200025, China.
Yiqing ShiDepartment of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Yimei JiangDepartment of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Changgang WangDepartment of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Xianze ChenDepartment of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Xiaopin JiDepartment of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China. surgeonjee@hotmail.com.
Ren ZhaoDepartment of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China. zhaorensurgeon@aliyun.com.ORCID http://orcid.org/0000-0003-1978-5912
Shanghai Jiao Tong University · CN

Funding

Shanghai Hospital Development Center SHDC2020CR1026B
6 · The paper itself

Abstract

backgroundIn most previous studies, single-incision laparoscopic surgery (SILS) for colorectal cancer (CRC) was feasible and safe in the short term. However, long-term oncologic outcomes remain uncertain, as only a few studies contained long-term survival data. SILS for CRC is still in the early stages of research. Further studies, particularly large-scale, prospective randomized controlled trials, are necessary to assess the value of SILS for CRC.

methodsThis study is a prospective, multicentre, open-label, noninferiority, parallel-group randomized controlled trial that investigates the long-term oncologic outcomes of SILS compared to conventional laparoscopic surgery (CLS) for CRC. A total of 710 eligible patients will be randomly assigned to the SILS group or the CLS group at a 1:1 ratio using a central, dynamic, and stratified block randomization method. Patients with ages ranging from 18 to 85 years old, of both sexes, with CRC above the peritoneal reflection diagnosed as cT1-4aN0-2M0 and a tumour size no larger than 5 cm will be considered for the study. The primary endpoint is 3-year disease-free survival (DFS). The secondary endpoints include: intraoperative outcomes, postoperative recovery, postoperative pain assessment, pathological outcomes, early morbidity and mortality rate, cosmetic effects, quality of life, 3-year overall survival (OS), incidence of incisional hernia, 5-year DFS and 5-year OS. The first two follow-up visits will be scheduled at one month and three months postoperatively, then every three months for the first two years and every six months for the next three years. DISCUSSION: Currently, no randomized controlled trials (RCTs) have been designed to investigate the long-term oncologic outcomes of SILS for CRC. This study is expected to provide clinical evidence of the oncologic outcomes of SILS compared to CLS for CRC to promote its widespread use.

trial registrationClinicalTrials.gov:  NCT04527861 (registered on August 27, 2020).

Indexed as

Colorectal NeoplasmsLaparoscopySurgical WoundAdolescentAdultAgedAged, 80 and overColectomyEquivalence Trials as TopicFemaleHumansLength of StayMaleMiddle AgedMulticenter Studies as TopicOperative TimeColorectal cancerLaparoscopic surgeryOncologic outcomesRandomized controlled trialSingle-incisionStudy protocol

Identifiers

PMID35799145
PMCPMC9264567
OpenAlexW4284886704

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.