Evidence map›Paper›PMID 28417196›Full record

Trial reportInternational journal of colorectal disease2017

A sustaining rod increases necrosis of loop ileostomies: a randomized controlled trial.

Joel Zindel, Chantal Gygax, Peter Studer, Melanie Kauper, Daniel Candinas, Vanessa Banz, Lukas E Brügger

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

Trial report in International journal of colorectal disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00959738 (A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod), which is not on this map. Cited by 9 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 4 pooled it
1.2field-weighted citation impact, top 20% 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.

NCT00959738 naterminatednot on this map

A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2008 to 2014Enrolled121ConditionsIleostomy, Rectal NeoplasmsArmsDiverting loop ileostomy with rod, diverting loop ileostomy without rod
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Review
  7. Current Management of Intestinal Stomas and Their Complications.Journal of the anus, rectum and colon · 2020
    Review
  8. Ostomy Complications in Crohn's Disease.Clinics in colon and rectal surgery · 2019
    Review
  9. Ostomy-Related Complications.Clinics in colon and rectal surgery · 2019
    Review
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

7 authors at 3 institutions in 1 country.

Joel ZindelInselspital, University Hospital Bern and University of Bern, CH-3010, Bern, Switzerland.
Chantal GygaxInselspital, University Hospital Bern and University of Bern, CH-3010, Bern, Switzerland.
Peter StuderInselspital, University Hospital Bern and University of Bern, CH-3010, Bern, Switzerland.
Melanie KauperDepartment of Visceral Surgery, Kantonsspital Luzern, CH-6000 Luzern and Spital Tafers, CH-1712, Tafers, Switzerland.
Daniel CandinasInselspital, University Hospital Bern and University of Bern, CH-3010, Bern, Switzerland.
Vanessa BanzInselspital, University Hospital Bern and University of Bern, CH-3010, Bern, Switzerland.
Lukas E BrüggerInselspital, University Hospital Bern and University of Bern, CH-3010, Bern, Switzerland. lukas.bruegger@insel.ch.
University Hospital of Bern · CHUniversity of Bern · CHLuzerner Kantonsspital · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDefunctioning loop ileostomies (LI) are commonly used in colorectal surgery to reduce the potentially detrimental consequences of anastomotic leakages. However, stoma-related morbidity is high with up to 75% of patients having local complications. The aim of this study was to investigate the effect of a sustaining rod on the local complication rate.

methodsIn this prospective, multi-center, randomized controlled trial, subjects were allocated to either a rod or a rod-less protocol (NCT00959738). The primary outcome was local morbidity as measured by a stoma specific morbidity score (SSMS) during the first 3 months postoperatively.

resultsBetween August 2008 and July 2014, a total of 122 patients were enrolled in the study, of which 78 (63.8%) completed the study [44 (56.4%) rod, 34 (43.6%) rod-less]. There was no significant difference in the SSMS between the two groups. The incidence of necrosis or partial necrosis, however, was significantly increased in the rod group: 13 (29.5%) vs. 1 (2.9%) in the rod-less group (p < 0.01). The retraction rate did not differ significantly between the groups: two (4.5%) in the rod vs. five (14.7%) in the rod-less group (p = 0.13). High body mass index (BMI > 26) was associated with an odds ratio of 5 (p < 0.01) for severe stoma complications.

conclusionsA rod-less technique for loop ileostomies reduces the risk of stomal necrosis, with a high BMI being an independent risk factor for stomal complications.

Indexed as

IleostomyDemographyEndpoint DeterminationFemaleHumansMaleMiddle AgedNecrosisQuality of LifeSurgical StomasDefunctioning stomaLocal stomal complicationsLoop ileostomySustaining rod

Identifiers

PMID28417196
OpenAlexW2605838646

What OpenQuestion holds

Textmetadata
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.