Evidence map›Paper›PMID 26441180›Full record

Trial reportJAMA2015

Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial.

Andrew R L Stevenson, Michael J Solomon, John W Lumley, Peter Hewett, Andrew D Clouston, Val J Gebski, Lucy Davies, Kate Wilson, Wendy Hague, John Simes and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in JAMA, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 490 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
490citing papers in PubMed, 17 pooled it
42.1field-weighted citation impact, top 1% 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.

NCT03574493 completednot on this mapstarted 2018, after this paper: background citation

Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

Typeobservational_patient_registrySponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2018 to 2024Enrolled1,098ConditionsRectal CancerArmsTME with LAR
NCT03683446 completednot on this map

Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer From 2005 to 2016 Using the ACS-NSQIP Database, a Retrospective Cohort Study

Typeobservational_patient_registrySponsorCatherine H. Davis, MDRan2005 to 2017Enrolled31,795ConditionsColorectal Adenocarcinoma, Colorectal SurgeryArmsLaparoscopic rectal surgery, Open rectal surgery
3 · Its place in the literature

Who cites it

490 citing papers in PubMed, 17 syntheses or guidelines pooled it, 1,018 citations in OpenAlex.

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430 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Andrew R L StevensonFaculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, Australia2Royal Brisbane and Women's Hospital, Brisbane, Australia.
Michael J SolomonInstitute of Academic Surgery, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.
John W LumleyWesley Hospital, Brisbane, Australia.
Peter HewettAdelaide University Department of Surgery, Queen Elizabeth Hospital, Adelaide, Australia.
Andrew D CloustonFaculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, Australia2Royal Brisbane and Women's Hospital, Brisbane, Australia.
Val J GebskiNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Lucy DaviesNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Kate WilsonNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Wendy HagueNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
John SimesNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
ALaCaRT Investigators
University of Sydney · AUNational Health and Medical Research Council · AUUniversity of Queensland · AUQueen Elizabeth Hospital · AUWesley Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

importanceLaparoscopic procedures are generally thought to have better outcomes than open procedures. Because of anatomical constraints, laparoscopic rectal resection may not be better because of limitations in performing an adequate cancer resection.

objectiveTo determine whether laparoscopic resection is noninferior to open rectal cancer resection for adequacy of cancer clearance. DESIGN, SETTING, AND

participantsRandomized, noninferiority, phase 3 trial (Australasian Laparoscopic Cancer of the Rectum; ALaCaRT) conducted between March 2010 and November 2014. Twenty-six accredited surgeons from 24 sites in Australia and New Zealand randomized 475 patients with T1-T3 rectal adenocarcinoma less than 15 cm from the anal verge.

interventionsOpen laparotomy and rectal resection (n = 237) or laparoscopic rectal resection (n = 238). MAIN OUTCOMES AND MEASURES: The primary end point was a composite of oncological factors indicating an adequate surgical resection, with a noninferiority boundary of Δ = -8%. Successful resection was defined as meeting all the following criteria: (1) complete total mesorectal excision, (2) a clear circumferential margin (≥1 mm), and (3) a clear distal resection margin (≥1 mm). Pathologists used standardized reporting and were blinded to the method of surgery.

resultsA successful resection was achieved in 194 patients (82%) in the laparoscopic surgery group and 208 patients (89%) in the open surgery group (risk difference of -7.0% [95% CI, -12.4% to ∞]; P = .38 for noninferiority). The circumferential resection margin was clear in 222 patients (93%) in the laparoscopic surgery group and in 228 patients (97%) in the open surgery group (risk difference of -3.7% [95% CI, -7.6% to 0.1%]; P = .06), the distal margin was clear in 236 patients (99%) in the laparoscopic surgery group and in 234 patients (99%) in the open surgery group (risk difference of -0.4% [95% CI, -1.8% to 1.0%]; P = .67), and total mesorectal excision was complete in 206 patients (87%) in the laparoscopic surgery group and 216 patients (92%) in the open surgery group (risk difference of -5.4% [95% CI, -10.9% to 0.2%]; P = .06). The conversion rate from laparoscopic to open surgery was 9%. CONCLUSIONS AND RELEVANCE: Among patients with T1-T3 rectal tumors, noninferiority of laparoscopic surgery compared with open surgery for successful resection was not established. Although the overall quality of surgery was high, these findings do not provide sufficient evidence for the routine use of laparoscopic surgery. Longer follow-up of recurrence and survival is currently being acquired.

trial registrationanzctr.org Identifier: ACTRN12609000663257.

Indexed as

LaparotomyAdenomaAdultDigestive System Surgical ProceduresDisease-Free SurvivalFemaleHumansLaparoscopyMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm, ResidualQuality of LifeRectal NeoplasmsSingle-Blind MethodTreatment Outcome

Identifiers

PMID26441180
OpenAlexW1926888387

What OpenQuestion holds

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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.