Evidence map›Paper›PMID 37037856›Full record

Trial reportScientific reports2023

Early versus late reversal of diverting loop ileostomy in rectal cancer surgery: a multicentre randomized controlled trial.

Mark Bremholm Ellebæk, Sharaf Karim Perdawood, Signe Steenstrup, Sardar Khalaf, Jette Kundal, Sören Möller, Jacob Christian Bang, Jens Støvring, Niels Qvist

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01865071 (Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 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.

NCT01865071 naunknown statusnot on this map

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

TypeinterventionalSponsorOdense University HospitalRan2011 to 2015Enrolled150ConditionsRectal CancerArmsloop ileostomi
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

9 authors.

Mark Bremholm EllebækResearch Unit of Surgery, Odense University Hospital, Odense, Denmark. markep01@gmail.com.
Sharaf Karim PerdawoodDepartment of Gastrointestinal Surgery, Slagelse Hospital, Slagelse, Denmark.
Signe SteenstrupResearch Unit of Surgery, Odense University Hospital, Odense, Denmark.
Sardar KhalafResearch Unit of Surgery, Odense University Hospital, Odense, Denmark.
Jette KundalResearch Unit of Surgery, Odense University Hospital, Odense, Denmark.
Sören MöllerOPEN, Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark.
Jacob Christian BangDepartment of Radiology, Svendborg Hospital, Svendborg, Denmark.
Jens StøvringDepartment of Surgery, Hospital South West Jutland, Esbjerg, Denmark.
Niels QvistResearch Unit of Surgery, Odense University Hospital, Odense, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Diverting loop ileostomy has become routine in low anterior resection (LAR) for rectal cancer. The optimal time for stoma reversal is controversial. The aim of the present study was to compare the results after planned early (within 8-12 days) versus late (> 3 months) stoma reversal. The primary outcomes were morbidity and mortality, as measured by the Comprehensive Complication Index (CCI) within 30 days after stoma reversal, and the secondary outcomes were morbidity and mortality within 90 days after LAR. This was a multicentre trial including all patients scheduled for anterior low resection for rectal cancer with curative intent. Inclusion period was from April 2011 to December 2018. All patients were randomized 1:1 prior to surgery. Among 257 consecutive and eligible patients, a total of 214 patients were randomized: 107 patients to early stoma reversal and 107 to late reversal. A total of 68 patients were excluded for various reasons, and 146 patients completed the study, with 77 in the early reversal group and 69 in the late reversal group. The patients were asked to complete the Gastrointestinal Quality of Life Index before surgery (baseline) and at 6 and 12 months after LAR. Ostomy-related complications were evaluated by dedicated ostomy staff using the validated DET score. ClinicalTrials Identifier: NCT01865071. Fifty-three patients (69%) in the early reversal group and 60 patients (87%) in the late reversal group received the intended treatment. There were no significant differences in CCI within 90 days after index surgery with the LAR and within 30 days after stoma reversal between the two groups. There were no differences in patient-reported quality of life but significantly more stoma-related complications in the late reversal group. A total of 5 patients experienced anastomotic leakage (AL) after stoma reversal, 4 in the early reversal group and one in the late reversal group. Early and late stoma reversal showed similar outcomes in terms of overall complications and quality of life. The risk of developing anastomotic leakage after early ostomy reversal is a concern.

Indexed as

IleostomyRectal NeoplasmsAnastomosis, SurgicalAnastomotic LeakHumansPostoperative ComplicationsQuality of LifeRetrospective Studies

Identifiers

PMID37037856
PMCPMC10085999

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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.