Evidence map›Paper›PMID 25830422›Full record

Trial reportThe New England journal of medicine2015

A randomized trial of laparoscopic versus open surgery for rectal cancer.

H Jaap Bonjer, Charlotte L Deijen, Gabor A Abis, Miguel A Cuesta, Martijn H G M van der Pas, Elly S M de Lange-de Klerk, Antonio M Lacy, Willem A Bemelman, John Andersson, Eva Angenete and 4 more

6 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 633 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
633citing papers in PubMed, 13 pooled it
64.9field-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.

NCT00297791 phase3completednot on this map

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

TypeinterventionalSponsorNova Scotia Health AuthorityRan2004 to 2015Enrolled1,044ConditionsRectal CancerArmssurgery
NCT02728427 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2016 to 2018Enrolled120ConditionsRectal Cancer, SurgeryArmsSuprapubic catheterization using central venous catheter(CVC-2 7F), Transurethral catheterization using Foley catheter
NCT02954913 nacompletednot on this mapstarted 2017, after this paper: background citation

Simultaneous RESEction of Colorectal Cancer With Synchronous Liver MeTastases (RESECT): A Feasibility Study

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2017 to 2021Enrolled41ConditionsColoRectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, SurgeryArmsSimultaneous Resection
NCT04200027 not yet recruitingnot on this mapstarted 2021, after this paper: background citation

Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon

Typeobservational_patient_registrySponsorOdense University HospitalRan2021 to 2026Enrolled330ConditionsRectal CancerArmstotal mesorectal excision
NCT04936581 recruitingnot on this mapstarted 2021, after this paper: background citation

Patient Reported Outcomes Following Cancer of the Rectum

TypeobservationalSponsorUniversity Hospital Gregorio MarañónRan2021 to 2028Enrolled200ConditionsSphincter Ani Incontinence, Rectal CancerArmsOpen Total Mesorectal Excision, Laparoscopic Total Mesorectal Excision, Robotic Total Mesorectal Excision, Transanal Total Mesorectal Excision
NCT06204497 nacompletednot on this mapstarted 2024, after this paper: background citation

The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study

TypeinterventionalSponsorSir Run Run Shaw HospitalRan2024 to 2025Enrolled570ConditionsRectal NeoplasmsArmsStent-based Diverting Technique
3 · Its place in the literature

Who cites it

633 citing papers in PubMed, 13 syntheses or guidelines pooled it, 1,416 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 6 countries.

H Jaap BonjerFrom VU University Medical Center (H.J.B., C.L.D., G.A.A., M.A.C., M.H.G.M.P., E.S.M.L.-K.) and Amsterdam Medical Center (W.A.B.) - both in Amsterdam; Hospital Clinic I Provincial de Barcelona, Barcelona (A.M.L.); the Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital-Östra, Gothenburg, Sweden (J.A., E.A., E.H.); Herlev Hospital, Department of Surgery, University of Copenhagen, Copenhagen (J.R.); and Caritas Krankenhaus St. Josef, Regensburg, Germany (A.F.).
Charlotte L Deijen
Gabor A Abis
Miguel A Cuesta
Martijn H G M van der Pas
Elly S M de Lange-de Klerk
Antonio M Lacy
Willem A Bemelman
John Andersson
Eva Angenete
Jacob Rosenberg
Alois Fuerst
Eva Haglind
COLOR II Study Group
University Medical Center · USSahlgrenska University Hospital · SEAmsterdam UMC Location VUmc · NLAmsterdam University Medical Centers · NLCaritas-Krankenhaus St. Josef · DEHospital Clínic de Barcelona · ESUniversity Hospital and Clinics · USUniversity of Copenhagen · DKUniversity of Gothenburg · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLaparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer.

methodsIn this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival.

resultsA total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8).

conclusionsLaparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.).

Indexed as

LaparoscopyAdenocarcinomaAgedDigestive System Surgical ProceduresDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingRectal NeoplasmsSurvival Rate

Identifiers

PMID25830422
OpenAlexW2011743240

What OpenQuestion holds

Textmetadata
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.