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NCT05264467
Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Phase 2, PHASE3 trial testing Platelet rich fibrin on colorectal anastomosis in Anastomotic Leak in 106 participants. Completed in 10 August 2021.
9 July 2021
Quick facts
| Lead sponsor | Universidad de Concepcion |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 106 |
| Start date | 12 March 2018 |
| Primary completion | 9 July 2021 |
| Estimated completion | 10 August 2021 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Platelet rich fibrin on colorectal anastomosis — full drug profile →
Conditions studied
- Anastomotic Leak — all drugs for Anastomotic Leak →
- Platelet-Rich Fibrin — all drugs for Platelet-Rich Fibrin →
- Colorectal Surgery — all drugs for Colorectal Surgery →
Sponsor
Universidad de Concepcion — full company profile →
Who can join
15 and older, any sex, with Anastomotic Leak or Platelet-Rich Fibrin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.
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 NCT05264467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Anastomotic Leak
Currently open trials in the same condition.
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- NCT07144683 — Anastomotic Leakage After Colorectal Surgery. · recruiting
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Other Universidad de Concepcion trials
Trials by the same sponsor.
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- NCT05609760 — Pictograms to Facilitate Comprehension of Medical Indications · NA · terminated
- NCT07087704 — Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia · NA · completed
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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 NCT05264467 (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 Universidad de Concepcion
- Last refreshed: 3 March 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/NCT05264467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing