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

NCT ID: NCT05264467

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2021-08-10

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.

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 colorectal anastomotic leakage varies between 4 and 20%, and it definition is dissimilar depending on the articles reviewed. However, results from the Dutch Colorectal Surgery Audit, published in 2010 showed a global leakage rate of 11%.

To decrease this surgical complication several strategies and devices have been developed with discouraging results. Based on the scar theory of platelet concentrates, the use of platelet-rich plasma (PRF) and leukocyte and platelet-rich fibrin plasma (L-PRF) has been proposed to stimulate and improve cicatrization in colorectal anastomosis, showing promising results in animal studies.

L-PRF is a second generation platelet concentrate of better quality and simpler confection, that is obtained by a similar technique developed in France by Choukroun et al, in the absence of anticoagulants or gelling agents. Platelet concentrates and specially L- PRF are use in various areas of odontology and medicine, including colorectal surgery.

The main objective of this study was to evaluate the feasibility of using L-PRF in colorectal surgery and to determine its effect on anastomotic leakage after colorectal anastomosis.

This study was approved by the Ethical and Scientific Committee of Health Service of Concepción city (Code: 17-07-40). All participants were explained their rights and were asked for their consent to enroll them in the study. On the other hand, anonymity and confidentiality of the participants was assured during the study, as the patients personal information was not included in the research database, which was administered only by the main investigator and the statistical analyst.

This study was held following the recommendations of Helsinski Declaration and World Medical Association.

Conditions

Anastomotic Leak; Platelet-Rich Fibrin; Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

PRF

Group Type: EXPERIMENTAL

Platelet rich fibrin on colorectal anastomosis

Intervention Type: BIOLOGICAL

Platelet rich fibrin on colorectal anastomosis

Interventions

Platelet rich fibrin on colorectal anastomosis

Platelet rich fibrin on colorectal anastomosis

Intervention Type: BIOLOGICAL

Other Intervention Names

Control

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Concepcion

OTHER

Sponsor Role: lead

Responsible Party

José Vivanco Aguilar

physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Regional Concepción

Concepción, , Chile

Countries

Chile

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UdeConcepcion

Identifier Type: -

Identifier Source: org_study_id