Evidence map›Paper›PMID 37684648›Full record

ArticleTrials2023

PHaLIR: prevent hernia after loop ileostomy reversal-a study protocol for a randomized controlled multicenter study.

Karolina Eklöv, Sven Bringman, Jenny Löfgren, Jonas Nygren, Åsa H Everhov

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03720262 (Prevention of Hernia After Loop Ileostomy Reversal), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 74% 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.

NCT03720262 phase2 / phase3recruitingnot on this map

Prevention of Hernia After Loop Ileostomy Reversal

TypeinterventionalSponsorKarolinska InstitutetRan2018 to 2029Enrolled208ConditionsLoop IleostomyArmsMesh reinforcement, No reinforcement
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.

  1. Pooled it
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

5 authors at 2 institutions in 1 country.

Karolina EklövDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Stockholm, Sweden. karolina.eklov@ki.se.ORCID http://orcid.org/0000-0001-5059-5856
Sven BringmanDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Stockholm, Sweden.
Jenny LöfgrenDepartment of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.
Jonas NygrenDepartment of Surgery, Ersta Hospital, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Åsa H EverhovDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Stockholm, Sweden.
Karolinska Institutet · SEKarolinska University Hospital · SE

Funding

Kommunfullmäktige, Stockholms Stad FoUI-953977
6 · The paper itself

Abstract

backgroundRectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7-15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies.

methodsThe present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18-90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications. DISCUSSION: This double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure.

trial registrationClinicalTrials.gov NCT03720262. Registered on October 25, 2018.

Indexed as

Abdominal WallSurgical StomasAdolescentAdultAgedAged, 80 and overEquivalence Trials as TopicHumansIleostomyLength of StayMiddle AgedMulticenter Studies as TopicNeurosurgical ProceduresRandomized Controlled Trials as TopicYoung AdultHerniaLoop ileostomy reversalPrevent herniaRectal cancer

Identifiers

PMID37684648
PMCPMC10486037
OpenAlexW4386544153

What OpenQuestion holds

Textmetadata
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.