LIFT With or Without Injection of BM-MNCs

November 23, 2021 updated by: Sameh Emile, Mansoura University

Ligation of Intersphincteric Fistula Tract (LIFT) With or Without Injection of Bone Marrow Mononuclear Cells in Treatment of Trans-sphincteric Anal Fistula; a Randomized Controlled Trial

To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia.

A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35516
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients of either gender presented with cryptoglandular trans-sphincteric anal fistula

Exclusion Criteria:

  • Patients with secondary anal fistula
  • Immunocompromised patients
  • Patients with previous pelvic radiotherapy
  • Pregnant women
  • Patients with ASA (American society of anesthesiologists) III or higher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LIFT
Patients underwent LIFT proecdure
Procedure: LIFT
The fistula tract is ligated in the intersphincteric space
ACTIVE_COMPARATOR: LIFT+bone marrow mononuclear cell injection
Patients underwent LIFT with bone marrow mononuclear cell injection
Procedure: LIFT
The fistula tract is ligated in the intersphincteric space
Procedure: bone marrow mononuclear cell injection
bone marrow mononuclear cells were injected in the intersphincteric space and around the internal opening after ligation and division of the tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with complete healing of anal fistula as assessed by clinical examination
Time Frame: 6 months
Healing is defined as complete epithelization of the anal wound with absence of fistula tract
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ACTUAL)

November 1, 2021

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (ACTUAL)

November 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura2022LIFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anal Fistula

Clinical Trials on LIFT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe