Last reviewed · How we verify
NCT04357171: PROTECT
PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
NA trial testing Low anterior resection with protective loop ileostomy in Rectal Cancer in 202 participants. Completed in 2 February 2020.
2 February 2020
Quick facts
| Lead sponsor | Russian Society of Colorectal Surgeons |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 202 |
| Start date | 14 January 2012 |
| Primary completion | 2 February 2020 |
| Estimated completion | 2 February 2020 |
Drugs / interventions tested
- Low anterior resection with protective loop ileostomy
- Low anterior resection with protective loop transverse colostomy
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
Russian Society of Colorectal Surgeons
Who can join
Adults 18 to 85, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate. This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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 NCT04357171
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rectal Cancer
Currently open trials in the same condition.
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07537998 — Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a · Phase 2, PHASE3 · recruiting
- NCT07501845 — Registry Maastro Applicator · recruiting
- NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
- NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting
Other Russian Society of Colorectal Surgeons trials
Trials by the same sponsor.
- NCT06119867 — CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE) · Phase 3 · recruiting
- NCT05715983 — Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure. · NA · unknown
- NCT04364373 — D2 vs D3 Lymph Node Dissection for Left Colon Cancer · NA · recruiting
- NCT04361695 — Preemptive Analgesia for Hemorrhoidectomy · NA · unknown
- NCT04288349 — IntraopeRativE Use of periNeal Block for Hemorrhoidectomy · NA · unknown
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 NCT04357171 (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 Russian Society of Colorectal Surgeons
- Last refreshed: 22 April 2020
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/NCT04357171.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing