Evidence map›Paper›PMID 30080730›Full record

Trial reportAnnals of surgery2019

Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.

James Fleshman, Megan E Branda, Daniel J Sargent, Anne Marie Boller, Virgilio V George, Maher A Abbas, Walter R Peters, Dipen C Maun, George J Chang, Alan Herline and 15 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 206 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
206citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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

206 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  18. Robotic Beyond Total Mesorectal Excision With Synchronous Perineal Flap Reconstruction: Feasibility and Early Outcomes.The international journal of medical robotics + computer assisted surgery : MRCAS · 2026
    Article
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146 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

James FleshmanBaylor University Medical Center, Department of Surgery, 3500 Gaston Avenue, 1 Floor Roberts Hospital, Dallas, TX.
Megan E BrandaAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Daniel J SargentFormerly with Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Anne Marie BollerNorthwestern University, Keck School of Medicine, Chicago, IL.
Virgilio V GeorgeMedical University of South Carolina, Charleston, SC.
Maher A AbbasDubai Colorectal and Digestive Clinic, Dubai, United Arab EmiratesWashington University School of Medicine, St. Louis, MO.
Walter R PetersBaylor University Medical Center, Dallas, TX.
Dipen C MaunFranciscan Health, Indianapolis, IN.
George J ChangThe University of Texas M.D. Anderson Cancer Center, Houston, TX.
Alan HerlineAugusta University, Augusta, GA.
Alessandro FicheraUniversity of North Carolina, Chapel Hill, NC.
Matthew G MutchMayo Clinic, Rochester, MN.
Steven D WexnerCleveland Clinic-Weston, Fort Lauderdale, FL.
Mark H WhitefordThe Oregon Clinic, Oregon Health and Sciences University, Portland, OR.
John MarksLankenau Hospital, Main Line Health, Wynnewood, PA.
Elisa BirnbaumUniversity of Colorado Denver, Denver, CO.
David A MargolinOchsner Clinic Foundation, New Orleans, LA.
David W LarsonMayo Clinic, Rochester, MN.
Peter W MarcelloLahey Hospital & Medical Center, Burlington, MA.
Mitchell C PosnerUniversity of Chicago Medicine, Chicago, IL.
Thomas E ReadLahey Hospital & Medical Center, Burlington, MA.
John R T MonsonFlorida Hospital Medical Group, Orlando, FL.
Sherry M WrenStanford University School of Medicine, Palo Alto Veterans Health Care System, Palo Alto, CA.
Peter W T PistersThe University of Texas M.D. Anderson Cancer Center, Houston, TX.
Heidi NelsonMayo Clinic, Rochester, MN.

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP)U10CA180858 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUNT, KELLY K, PINNIX, CHELSEA CAMILLE · 2014 to 2018
$5.6M
NCI National Clinical Trials Network-Network Lead Academic Participating SitesU10CA180836 · NCI · UNIVERSITY OF CHICAGO · PI CHMURA, STEVEN J, KINDLER, HEDY L · 2014 to 2018
$3.2M
NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180836NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233329
6 · The paper itself

Abstract

objectiveTo determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection.

backgroundThis randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051.

methodsThe DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months.

resultsThe 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77).

conclusionLaparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

Indexed as

LaparoscopyDigestive System Surgical ProceduresDisease-Free SurvivalFollow-Up StudiesHumansNeoplasm Recurrence, LocalNeoplasm StagingRectal Neoplasms

Identifiers

PMID30080730
PMCPMC6360134

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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.