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

Sponsor
Universidad de Concepcion (Other)
Overall Status
Completed
CT.gov ID
NCT05264467
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
41
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Platelet rich fibrin on colorectal anastomosis
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized one blinded experimental designA randomized one blinded experimental design
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Use of Leukocyte and and Platelet-rich Fibrin Plasma (L-PRF) for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Actual Study Start Date :
Mar 12, 2018
Actual Primary Completion Date :
Jul 9, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control
Experimental: PRF

Biological: Platelet rich fibrin on colorectal anastomosis
Platelet rich fibrin on colorectal anastomosis
Other Names:
  • Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine the incidence of anastomotic leakage after colorectal anastomosis [30 days]

      Anastomotic leak description in both arms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Regional Concepción Concepcion Chile 4030000

    Sponsors and Collaborators

    • Universidad de Concepcion

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    José Vivanco Aguilar, physician, Universidad de Concepcion
    ClinicalTrials.gov Identifier:
    NCT05264467
    Other Study ID Numbers:
    • UdeConcepcion
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anastomotic Leak

    Study Results

    No Results Posted as of Mar 3, 2022