Last reviewed · How we verify

NCT04372992: STOMAD

The Stoma Closure Before or After Adjuvant Therapy Trial

Terminated NA Last updated 22 September 2022
What this trial tests

NA trial testing Timing of stoma closure in Ileostomy in 14 participants. Terminated before completion.

Timeline
1 September 2020
Primary endpoint
1 September 2022
1 September 2022

Quick facts

Lead sponsorOspedale Umberto I di Torino
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment14
Start date1 September 2020
Primary completion1 September 2022
Estimated completion1 September 2022
Sites28 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Ospedale Umberto I di Torino

Who can join

18 and older, any sex, with Ileostomy or Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a curative resection for rectal cancer and temporary ileostomy, 270 patients with indication to adjuvant chemotherapy will be randomized to early (before starting adjuvant treatment) or late (after adjuvant treatment completion) stoma closure. Primary end point will the compliance to adjuvant therapy. Secondary endpoint will include quality of life and bowel function evaluation, postoperative morbidity, chemotherapy toxicity, oncological outcomes and costs comparison.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before
    Massucco P, Fontana A, Mineccia M, Perotti S, et al · · 2021 · cited 10× · PMID 33608405 · DOI 10.1136/bmjopen-2020-044692
  2. Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.
    Vuyyuru SK, Ma C, Sharma T, Nguyen TM, et al · · 2024 · cited 3× · PMID 38135729 · DOI 10.1093/ibd/izad293

Verify or expand the search:

Other recruiting trials for Ileostomy

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04372992.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing