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NCT04372992: STOMAD
The Stoma Closure Before or After Adjuvant Therapy Trial
NA trial testing Timing of stoma closure in Ileostomy in 14 participants. Terminated before completion.
1 September 2022
Quick facts
| Lead sponsor | Ospedale Umberto I di Torino |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 14 |
| Start date | 1 September 2020 |
| Primary completion | 1 September 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 28 locations across Italy |
Drugs / interventions tested
- Timing of stoma closure
Conditions studied
- Ileostomy — all drugs for Ileostomy →
- Rectal Cancer — all drugs for Rectal Cancer →
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):
-
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 -
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:
- PubMed search for NCT04372992
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ileostomy
Currently open trials in the same condition.
- NCT06604052 — A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Tempo · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04372992 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ospedale Umberto I di Torino
- Last refreshed: 22 September 2022
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