LIFT With or Without Injection of BM-MNCs

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2021

Interventions

  • 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
  • Procedure: LIFT
    • The fistula tract is ligated in the intersphincteric space

Arms, Groups and Cohorts

  • Active Comparator: LIFT
    • Patients underwent LIFT proecdure
  • Active Comparator: LIFT+bone marrow mononuclear cell injection
    • Patients underwent LIFT with bone marrow mononuclear cell injection

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sameh Emile, Associate professor of surgery – Mansoura University

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