Evidence map›Paper›PMID 33549133›Full record

ArticleTrials2021

Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial.

Rui Luo, Fangfang Zheng, Haobo Zhang, Weiquan Zhu, Penghui He, Dongning Liu

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

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04230772 (A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 36% 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.

NCT04230772 naunknown statusnot on this map

A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer

TypeinterventionalSponsorTaiyuan LiRan2021 to 2022Enrolled550ConditionsColorectal Neoplasms, Neoplasms Malignant, Complication of Surgical Procedure, Robotic Surgical ProceduresArmsNatural Orifice Specimen Extraction Surgery, Traditional Robotic-assisted Surgery
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. 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

6 authors at 2 institutions in 1 country.

Rui Luo *The First Clinical Medical College of Nanchang University, Nanchang, 330000, China.
Fangfang Zheng *Department of Cardiology, The Third Hospital of Nanchang, Nanchang, 330000, China.
Haobo ZhangThe First Clinical Medical College of Nanchang University, Nanchang, 330000, China.
Weiquan ZhuDepartment of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, 330000, China.
Penghui HeDepartment of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, 330000, China.
Dongning LiuDepartment of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, 330000, China. liudongning1982@sina.com.ORCID http://orcid.org/0000-0003-1419-0055
Nanchang University · CNThird Hospital of Nanchang · CN

Funding

Key Research and Development Program of Jiangxi Province 20202BBG73032
6 · The paper itself

Abstract

backgroundNatural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. METHOD/

designAccordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. DISCUSSION: This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes.

trial registrationClinicalTrials.gov NCT04230772 . Registered on January 15, 2020.

Indexed as

Colorectal NeoplasmsLaparoscopyRobotic Surgical ProceduresEquivalence Trials as TopicHumansMinimally Invasive Surgical ProceduresMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeColorectal cancerNatural orifice extraction surgeryRandomized controlled trialRobotic surgery

Identifiers

PMID33549133
PMCPMC7866755
OpenAlexW3126832865

What OpenQuestion holds

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LicenceCC BY
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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.