Evidence map›Paper›PMID 29168881›Full record

Trial reportThe British journal of surgery2018

Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial).

J Park, A K Danielsen, E Angenete, D Bock, A C Marinez, E Haglind, J E Jansen, S Skullman, A Wedin, J Rosenberg

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01287637 (Early Closure of Temporary Ileostomy- a Randomized Clinical Trial), which is not on this map. Cited by 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 10% 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.

NCT01287637 nacompletednot on this map

Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

TypeinterventionalSponsorHerlev HospitalRan2011 to 2015Enrolled89ConditionsRectal CancerArmsEarly reversal of temporary ileostomy, Standard reversal of temporary ileostomy
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.

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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

10 authors at 4 institutions in 2 countries.

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
A K DanielsenDepartment of Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej, Herlev, 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.
D BockDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.
A C MarinezDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.
E HaglindDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.ORCID 0000-0002-1147-5605
J E JansenDepartment of Surgery, Nordsjaellands Hospital, Hillerød, Denmark.
S SkullmanDepartment of Surgery, Skaraborgs Sjukhus, Skövde, Sweden.
A WedinDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital Östra, Gothenburg, Sweden.
J RosenbergDepartment of Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej, Herlev, Denmark.
Sahlgrenska University Hospital · SEUniversity of Copenhagen · DKNordsjællands Hospital · DKSkaraborg Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy.

methodsEarly closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Inclusion of participants was made after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1-4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®).

resultsThere were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12 months, to which only 54-55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months.

conclusionAlthough the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 (https://www.clinicaltrials.gov).

Indexed as

IleostomyQuality of LifeAdultAgedAged, 80 and overFemaleFollow-Up StudiesHealth Status IndicatorsHumansMaleMiddle AgedPostoperative ComplicationsRectal NeoplasmsRectumTime Factors

Identifiers

PMID29168881
PMCPMC5814870
OpenAlexW2769348216

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.