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

Primary Purpose

Anastomotic Leak, Platelet-Rich Fibrin, Colorectal Surgery

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Platelet rich fibrin on colorectal anastomosis
Sponsored by
Universidad de Concepcion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anastomotic Leak

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Regional Concepción

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PRF

Arm Description

Outcomes

Primary Outcome Measures

Determine the incidence of anastomotic leakage after colorectal anastomosis
Anastomotic leak description in both arms.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2022
Last Updated
February 28, 2022
Sponsor
Universidad de Concepcion
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1. Study Identification

Unique Protocol Identification Number
NCT05264467
Brief Title
Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Official Title
Use of Leukocyte and and Platelet-rich Fibrin Plasma (L-PRF) for the Prevention of Anastomotic Leakage in Colorectal Anastomosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Concepcion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak, Platelet-Rich Fibrin, Colorectal Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized one blinded experimental design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
PRF
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin on colorectal anastomosis
Other Intervention Name(s)
Control
Intervention Description
Platelet rich fibrin on colorectal anastomosis
Primary Outcome Measure Information:
Title
Determine the incidence of anastomotic leakage after colorectal anastomosis
Description
Anastomotic leak description in both arms.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Regional Concepción
City
Concepcion
ZIP/Postal Code
4030000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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