Evidence map›Paper›PMID 38135729›Full record

SynthesisInflammatory bowel diseases2024

Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.

Sudheer K Vuyyuru, Christopher Ma, Tanmay Sharma, Tran M Nguyen, Talat Bessissow, Neeraj Narula, Siddharth Singh, Florian Rieder, Vipul Jairath

Open access · greenAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Inflammatory bowel diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 22% 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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

9 authors at 6 institutions in 3 countries.

Sudheer K VuyyuruDivision of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, ON, Canada.
Christopher MaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-4698-9948
Tanmay SharmaDivision of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, ON, Canada.
Tran M NguyenLawson Health Research Institute, Western University, London, ON, Canada.
Talat BessissowDivision of Gastroenterology, Department of Medicine, McGill University Health Center, Montreal, QC, Canada.ORCID 0000-0003-2610-1910
Neeraj NarulaDivision of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada.ORCID 0000-0002-1536-8436
Siddharth SinghDivision of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.
Florian RiederDepartment of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, ON, Canada.ORCID 0000-0002-1092-0033
Western University · CACleveland Clinic · USMcGill University Health Centre · CAPopulation Health Research Institute · CAUniversity of Calgary · CAUniversity of California San Diego · US

Funding

Septins in intestinal fibrosisR01DK132038 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI Andrei Ivanovich Ivanov, Florian Rieder · 2023 to 2026
$2.5M
Creeping fat and Crohn's disease associated stricturesR01DK123233 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI RIEDER, FLORIAN · 2020 to 2024
$1.9M
Comparative effectiveness research in Hispanic patients with inflammatory bowel diseasesR01DK135937 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Siddharth Singh · 2024 to 2026
$1.9M
NIDDK NIH HHS R01 DK123233NIDDK NIH HHS R01 DK132038NIDDK NIH HHS R01 DK135937
6 · The paper itself

Abstract

backgroundThis systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn's disease (CD) and IS.

methodsWe searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm.

resultsA total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.

conclusionThere is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.

Indexed as

Clinical Trials as TopicInflammatory Bowel DiseasesSurgical StomasCrohn DiseaseHumansQuality of LifeRegistriesCrohn’sileostomyintestinal stomaulcerative colitis

Identifiers

PMID38135729
PMCPMC12102492
OpenAlexW4390152192

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.