Evidence map›Paper›PMID 31392405›Full record

Trial reportInternational journal of colorectal disease2019

Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial.

Simon Näverlo, Ulf Gunnarsson, Karin Strigård, Pia Näsvall

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00917995 (STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00917995 phase2 / phase3completednot on this map

STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

TypeinterventionalSponsorNorrbottens Lans LandstingRan2008 to 2015Enrolled241ConditionsParastomal HerniaArmsPolypropylene Mesh, density 25-40g/square meter
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Observational
  4. Article
  5. Article
  6. [Prophylaxis of parastomal, perineal and incisional hernias in colorectal surgery].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2021
    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

4 authors.

Simon NäverloDepartment of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 88, Umeå, Sweden. simon.naverlo@umu.se.ORCID http://orcid.org/0000-0001-5076-7400
Ulf GunnarssonDepartment of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 88, Umeå, Sweden.
Karin StrigårdDepartment of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 88, Umeå, Sweden.
Pia NäsvallDepartment of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 88, Umeå, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo determine whether prophylactic mesh in a sublay position has an impact on the quality-of-life (QoL) of patients receiving an end colostomy.

methodsOne-year follow-up of patients from the STOMAMESH trial, a randomized controlled double-blinded multicenter study. Patients were randomized to either prophylactic synthetic mesh with a cruciform incision in the center, placed in sublay position, or no prophylactic mesh. Patients attended a 1-year visit and responded to the questionnaires EORTC QLQ C-30 and CR-38. The impact of having a mesh on QoL was determined by comparing a group of patients receiving a mesh with a group without. A subgroup analysis was made depending on whether a PSH was clinically present or not.

resultsOf the 232 randomized patients, 211 patients reached the 1-year clinical follow-up. The response rate of these 211 patients was 70%. No differences were seen in global QoL between the groups. Mesh patients reported significantly less stoma-related problems (p = 0.014) but more sexual problems in males (p = 0.022). When excluding patients with a clinical diagnosis of PSH, the difference in stoma-related problems remained while no significant difference was seen regarding sexual problems in males.

conclusionsWhen forming an end colostomy, prophylactic synthetic mesh in a sublay position did not affect global QoL at 1-year follow-up, but stoma-related problems were fewer even in the presence of a clinically diagnosed PSH.

trial registrationNCT00917995.

Indexed as

ColostomyQuality of LifeSurgical MeshSurgical StomasAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedSurveys and QuestionnairesMeshParastomal herniaProphylaxisQuality-of-life

Identifiers

PMID31392405

What OpenQuestion holds

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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.