Evidence map›Paper›PMID 35773492›Full record

Trial reportInternational journal of colorectal disease2022

The impact of anastomotic leak on long-term oncological outcomes after low anterior resection for mid-low rectal cancer: extended follow-up of a randomised controlled trial.

Quoc Riccardo Bao, Gianluca Pellino, Gaya Spolverato, Angelo Restivo, Simona Deidda, Giulia Capelli, Cesare Ruffolo, Francesco Bianco, Dajana Cuicchi, Elio Jovine and 10 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of colorectal disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01110798 (Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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.

NCT01110798 naunknown statusnot on this map

Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer: Impact on Anastomotic Leak, Bowel Function and Quality of Life

TypeinterventionalSponsorAzienda Ospedaliera di PadovaRan2009Enrolled600ConditionsColorectal Cancer, Gastrointestinal Complications, Perioperative/Postoperative ComplicationsArmsintraoperative complication management/prevention, assessment of therapy complications, gastrointestinal complications management/prevention, quality-of-life assessment, therapeutic conventional surgery
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Review
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  11. Review
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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

20 authors.

Quoc Riccardo BaoGeneral Surgery 3, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
Gianluca PellinoDepartment of Advanced Medical and Surgical Sciences, Università Degli Studi Della Campania "Luigi Vanvitelli", Naples, Italy.
Gaya SpolveratoGeneral Surgery 3, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Via Giustiniani 2, 35128, Padova, Italy. gaya.spolverato@unipd.it.
Angelo RestivoColorectal Surgery Unit, A.O.U. Cagliari, Department of Surgical Science, University of Cagliari, Cagliari, Italy.
Simona DeiddaColorectal Surgery Unit, A.O.U. Cagliari, Department of Surgical Science, University of Cagliari, Cagliari, Italy.
Giulia CapelliGeneral Surgery 3, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
Cesare RuffoloGeneral Surgery 3, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.
Francesco BiancoDepartment of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.
Dajana CuicchiGeneral Surgery Unit, Department of Alimentary Tract, IRCCS Azienda Ospedaliera Universitaria Di Bologna, Bologna, Italy.
Elio JovineGeneral Surgery and Emergency, IRCCS Azienda Ospedaliera Universitaria Di Bologna, Bologna, Italy.
Raffaele LombardiGeneral Surgery and Emergency, IRCCS Azienda Ospedaliera Universitaria Di Bologna, Bologna, Italy.
Claudio BellucoDepartment of Surgical Oncology, National Cancer Institute, Aviano, PN, Italy.
Antonio AmatoDepartment of Coloproctology, Sanremo Hospital, Sanremo, IM, Italy.
Filippo La TorreDivision of Emergency and Trauma Surgery, Emergency Department, Policlinico Umberto I, College of Medicine and Dentistry, Sapienza University, Rome, Italy.
Corrado AsteriaDepartment of General Surgery, Ospedale Carlo Poma, Mantua, Italy.
Aldo InfantinoSurgical Unit, Department of General Surgery, Santa Maria Dei Battuti Hospital, San Vito al Tagliamento (PN), Italy.
Tania ContardoDepartment of Surgery, Regional Centre for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy.
Paola Del BiancoClinical Research Unit, Istituto Oncologico Veneto IOV - IRCCS, Padua, Italy.
Paolo DelrioDepartment of Colorectal Surgical Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy.
Salvatore PucciarelliGeneral Surgery 3, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe impact of anastomotic leaks (AL) on oncological outcomes after low anterior resection for mid-low rectal cancer is still debated. The aim of this study was to evaluate overall survival (OS), disease-free survival (DFS), and local and distant recurrence in patients with AL following low anterior resection.

methodsThis is an extension of a multicentre RCT (NCT01110798). Kaplan-Meier method and the log-rank test were used to estimate and compare the 3-, 5-, and 10-year OS and DFS, and local and distant recurrence in patients with and without AL. Predictors of OS and DFS were evaluated using the Cox regression analysis as secondary aim.

resultsFollow-up was available for 311 patients. Of them, 252 (81.0%) underwent neoadjuvant chemoradiotherapy and 138 (44.3%) adjuvant therapy. AL occurred in 63 (20.3%) patients. At a mean follow-up of 69.5 ± 31.9 months, 23 (7.4%) patients experienced local recurrence and 49 (15.8%) distant recurrence. The 3-, 5-, and 10-year OS and DFS were 89.2%, 85.3%, and 70.2%; and 80.7%, 75.1%, and 63.5% in patients with AL, and 88.9%, 79.8% and 72.3%; and 83.7, 74.2 and 62.8%, respectively in patients without (p = 0.89 and p = 0.84, respectively). At multivariable analysis, AL was not an independent predictor of OS (HR 0.65, 95%CI 0.34-1.28) and DFS (HR 0.70, 95%CI 0.39-1.25), whereas positive circumferential resection margins and pathological stage impaired both.

conclusionsIn the context of modern multimodal rectal cancer treatment, AL does not affect long-term OS, DFS, and local and distant recurrence in patients with mid-low rectal cancer.

Indexed as

ProctectomyRectal NeoplasmsAnastomotic LeakDisease-Free SurvivalFollow-Up StudiesHumansNeoadjuvant TherapyNeoplasm Recurrence, LocalPrognosisRetrospective StudiesAnastomotic leakLow anterior resectionRectal cancerSurvivalTotal mesorectal excision

Identifiers

PMID35773492
PMCPMC9262787

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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.