Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis

NCT05264467 | Completed Phase 2

• 1 other identifier: UdeConcepcion
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anastomotic Leak; Platelet-Rich Fibrin; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Determine the incidence of anastomotic leakage after colorectal anastomosis

  Anastomotic leak description in both arms.

  30 days

Study Arms (2)

Control

NO INTERVENTION

PRF

EXPERIMENTAL

Biological: Platelet rich fibrin on colorectal anastomosis

Interventions

Platelet rich fibrin on colorectal anastomosis BIOLOGICAL

Platelet rich fibrin on colorectal anastomosis

Also known as: Control

PRF

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Concepcion: lead

Study Sites (1)

Hospital Regional Concepción

Concepción, 4030000, Chile

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Model Details: A randomized one blinded experimental design

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 3, 2022
• Study Start: March 12, 2018
• Primary Completion: July 9, 2021
• Study Completion: August 10, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)