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NCT04673526
Laparoscopic Intersphincteric Resection in Elderly Patients
NA trial testing Laparoscopic intersphincteric resection in Rectal Cancer in 400 participants. Completed in 31 December 2016.
31 December 2016
Quick facts
| Lead sponsor | ASL Verbano Cusio Ossola |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 1 January 2009 |
| Primary completion | 31 December 2016 |
| Estimated completion | 31 December 2016 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Laparoscopic intersphincteric resection
- Laparoscopic abdomino-perineal procedures
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
ASL Verbano Cusio Ossola
Who can join
70 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the present study is to assess if it is possible to offer intersphincteric rectal resection (IRR) to selected patients older than 70 years affected by ultra-low rectal cancer. The study, involving patients with rectal cancer at less than 5 cm from the anal verge, will compare elderly patients refusing standard sphincteric demolition and undergoing IRR, with some control groups (younger patients undergoing IRR, \>70 years old patients undergoing abdominoperineal resection + colostomy in left iliac fossa, \>70 years old patients undergoing abdominoperineal resection + perineal colostomy). The groups will be compared in terms of quality of life, quality of life associated to incontinence, overall survival, disease free survival and post-operative complications. This will be helpful to identify conditions for extending IRR to elderly patients. The study is run by Colo-rectal Surgery Unit at Policlinico San Matteo in Pavia (Italy) from 2009 to 2016, directly led by Dr. Sandro Zonta (principal investigator) and funded by the hospital itself.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04673526
- 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.
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- 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
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 NCT04673526 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ASL Verbano Cusio Ossola
- Last refreshed: 22 December 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/NCT04673526.
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