Evidence map›Paper›PMID 30706439›Full record

Trial reportThe British journal of surgery2019

Functional outcomes from a randomized trial of early closure of temporary ileostomy after rectal excision for cancer.

C Keane, J Park, S Öberg, A Wedin, D Bock, G O'Grady, I Bissett, J Rosenberg, E Angenete

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04372992 (Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer), which is not on this map. Cited by 45 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 6 pooled it
5.2field-weighted citation impact, top 4% 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.

NCT04372992 naterminatednot on this mapstarted 2020, after this paper: background citation

Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer

TypeinterventionalSponsorOspedale Umberto I di TorinoRan2020 to 2022Enrolled14ConditionsIleostomy, Rectal CancerArmsTiming of stoma closure
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 6 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
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  5. The incidence and risk factors of low anterior resection syndrome (LARS) after sphincter-preserving surgery of rectal cancer: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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  16. Effectiveness of transanal irrigation in low anterior resection syndrome.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 3 countries.

C KeaneDepartment of Surgery, Faculty of Medicine and Health Sciences, University of Auckland, New Zealand.ORCID 0000-0002-9611-2335
J ParkDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.ORCID 0000-0001-9602-475X
S ÖbergCentre for Perioperative Optimization, Department of Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
A WedinDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.
D BockDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.
G O'GradyDepartment of Surgery, Faculty of Medicine and Health Sciences, University of Auckland, New Zealand.
I BissettDepartment of Surgery, Faculty of Medicine and Health Sciences, University of Auckland, New Zealand.
J RosenbergCentre for Perioperative Optimization, Department of Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
E AngeneteDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.ORCID 0000-0001-9966-4904
Sahlgrenska University Hospital · SEUniversity of Auckland · NZUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLow anterior resection syndrome (LARS) has a significant impact on postoperative quality of life. Although early closure of an ileostomy is safe in selected patients, functional outcomes have not been investigated. The aim was to compare bowel function and the prevalence of LARS in patients who underwent early or late closure of an ileostomy after rectal resection for cancer.

methodsEarly closure (8-13 days) was compared with late closure (after 12 weeks) of the ileostomy following rectal cancer surgery in a multicentre RCT. Exclusion criteria were: signs of anastomotic leakage, diabetes mellitus, steroid treatment and postoperative complications. Bowel function was evaluated using the LARS score and the Memorial Sloan Kettering Cancer Center Bowel Function Instrument (BFI).

resultsFollowing index surgery, 112 participants were randomized (55 early closure, 57 late closure). Bowel function was evaluated at a median of 49 months after stoma closure. Eighty-two of 93 eligible participants responded (12 had died and 7 had a permanent stoma). Rates of bowel dysfunction were higher in the late closure group, but this did not reach statistical significance (major LARS in 29 of 40 participants in late group and 25 of 42 in early group, P = 0·250; median BFI score 63 versus 71 respectively, P = 0·207). Participants in the late closure group had worse scores on the urgency/soiling subscale of the BFI (14 versus 17; P = 0·017). One participant in the early group and six in the late group had a permanent stoma (P = 0·054).

conclusionPatients undergoing early stoma closure had fewer problems with soiling and fewer had a permanent stoma, although reduced LARS was not demonstrated in this cohort. Dedicated prospective studies are required to evaluate definitively the association between temporary ileostomy, LARS and timing of closure.

Indexed as

AgedFecal IncontinenceFemaleFollow-Up StudiesHumansIleostomyIntestinesMaleMiddle AgedPostoperative ComplicationsProctectomyRectal NeoplasmsSyndromeTime Factors

Identifiers

PMID30706439
PMCPMC6590150
OpenAlexW2914445907

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.