Evidence map›Paper›PMID 29493785›Full record

Trial reportThe British journal of surgery2018

Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma-related complications (ISI trial).

M F Sier, D D Wisselink, D T Ubbink, R J Oostenbroek, G J Veldink, B Lamme, P van Duijvendijk, A A W van Geloven, Q A J Eijsbouts, W A Bemelman and 1 more

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 15% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. [Intestinal stomata].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2020
    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 12 institutions in 1 country.

M F SierDepartment of Surgery, University Medical Centre Leiden, Leiden, The Netherlands.
D D WisselinkDepartment of Surgery, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
D T UbbinkDepartment of Surgery, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
R J OostenbroekDepartment of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
G J VeldinkDepartment of Surgery, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
B LammeDepartment of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
P van DuijvendijkDepartment of Surgery, Gelre Hospital, Apeldoorn, The Netherlands.
A A W van GelovenDepartment of Surgery, Tergooi Hospital, Hilversum, The Netherlands.
Q A J EijsboutsDepartment of Surgery, Spaarne Gasthuis, Hoofddorp, The Netherlands.
W A BemelmanDepartment of Surgery, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands.
ISI trial study group
Academic Medical Center · NLAlbert Schweitzer Ziekenhuis · NLGelre Hospitals · NLLeiden University Medical Center · NLMáxima Medisch Centrum · NLRijnstate Hospital · NLSlotervaartziekenhuis · NLSpaarne Gasthuis · NLTergooi · NLUniversity Medical Center Utrecht · NLWestfriesgasthuis · NLZiekenhuis Amstelland · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIleostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous versus transcutaneous suturing of ileostomies on faecal leakage and quality of life.

methodsThis randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma-related quality of life and costs of stoma-related materials and reinterventions.

resultsBetween April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (52·4 versus 41·4 per cent respectively; risk difference 11·0 (95 per cent c.i. 0·3 to 21·2) per cent). Skin irritation rates were high (78·2 versus 72·2 per cent), but did not differ significantly between the groups (risk difference 6·1 (95 per cent c.i. -3·2 to 15·10) per cent). There were no significant differences in quality of life or costs between the groups.

conclusionIntracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma-related complications did not differ between the two techniques. Registration number: NTR2369 ( http://www.trialregister.nl).

Indexed as

Surgical StomasSuture TechniquesWound Closure TechniquesFemaleHumansIleostomyMaleMiddle Aged

Identifiers

PMID29493785
PMCPMC5947256
OpenAlexW2799482833

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.