Colorectal Surgery Clinical Trial
Official title:
Use of Leukocyte and and Platelet-rich Fibrin Plasma (L-PRF) for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Verified date | February 2022 |
Source | Universidad de Concepcion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | August 10, 2021 |
Est. primary completion date | July 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Regional Concepción | Concepcion |
Lead Sponsor | Collaborator |
---|---|
Universidad de Concepcion |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the incidence of anastomotic leakage after colorectal anastomosis | Anastomotic leak description in both arms. | 30 days |
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