LIFT With or Without Injection of BM-MNCs

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134168
• Other study ID #: Mansoura2022LIFT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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
• LIFT
The fistula tract is ligated in the intersphincteric space

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complete healing of anal fistula as assessed by clinical examination	Healing is defined as complete epithelization of the anal wound with absence of fistula tract	6 months