Status:
COMPLETED
Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Lead Sponsor:
Universidad de Concepcion
Conditions:
Anastomotic Leak
Platelet-Rich Fibrin
Eligibility:
All Genders
15+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Anastomotic leakage is an important and probably the most feared complication in colorectal surgery, due its high rate of morbidity, prolonged hospitalization and mortality. The incidence of colorect...
Eligibility Criteria
Inclusion
- Patients were submitted to elective colorectal anastomosis with mechanic anastomosis on or under the peritoneal reflection.
- Postoperative evaluation using contrast enema to objectify subclinical dehiscence.
Exclusion
- Age under 15 years
- American Association of Anesthesiologists (ASA) grade IV or higher.
- Clinical signs of peritonitis
- Other major surgeries within 30 days of the procedure.
- Deficient nutritional state (defined by plasmatic albumin levels lower tan 2.8 mg/dl) Active treatment with corticoids and the impossibility of having contrast enema post-surgery.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05264467
Start Date
March 12 2018
End Date
August 10 2021
Last Update
March 3 2022
Active Locations (1)
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1
Hospital Regional Concepción
Concepción, Chile, 4030000