Evidence map›Paper›PMID 30911920›Full record

Trial reportSurgical endoscopy2020

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

Jennifer Park, Eva Angenete, David Bock, Adiela Correa-Marinez, Anne K Danielsen, Jacob Gehrman, Eva Haglind, Jens E Jansen, Stefan Skullman, Anette Wedin and 1 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Surgical endoscopy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 13% 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
NCT04372992 naterminatednot on this map

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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Impact of ileostomy in the adjuvant treatment and outcome of colon cancer.International journal of colorectal disease · 2023
    Observational
  9. Observational
  10. Low anterior resection syndrome: can it be prevented?International journal of colorectal disease · 2021
    Review
  11. Article
  12. Article
  13. Article
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

11 authors at 4 institutions in 2 countries.

Jennifer ParkDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden. jennifer.park@vgregion.se.ORCID 0000-0001-9602-475X
Eva AngeneteDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.
David BockDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.
Adiela Correa-MarinezDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.
Anne K DanielsenDepartment of Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Jacob GehrmanDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.
Eva HaglindDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.
Jens E JansenDepartment of Surgery, Nordsjaellands Hospital, Hillerød, Denmark.
Stefan SkullmanDepartment of Surgery, Skaraborgs Sjukhus, Skövde, Sweden.
Anette WedinDepartment of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.
Jacob RosenbergDepartment of Surgery, Centre for Perioperative Optimization, Herlev and Gentofte Hospital, University of Copenhagen, 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

backgroundHospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial.

methodsEarly closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector.

resultsFifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations.

conclusionsThe significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL: Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

Indexed as

Anastomotic LeakIleostomyPostoperative ComplicationsProctectomyQuality of LifeAgedCosts and Cost AnalysisFemaleHumansMaleMiddle AgedRectal NeoplasmsTime-to-TreatmentTreatment OutcomeCost analysisRectal cancerRectal resectionTemporary ileostomy

Identifiers

PMID30911920
PMCPMC6946724
OpenAlexW2939228946

What OpenQuestion holds

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LicenceCC BY
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.