LIFT With or Without Injection of BM-MNCs

Not Applicable

Completed

• Conditions: Anal Fistula
• Interventions: Procedure: bone marrow mononuclear cell injection; Procedure: LIFT

• Registration Number: NCT05134168
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-09-01
• Status Verified: 2021-11
• Study Completion: 2021-11-01
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIFT+bone marrow mononuclear cell injection	bone marrow mononuclear cell injection	Patients underwent LIFT with bone marrow mononuclear cell injection
LIFT+bone marrow mononuclear cell injection	LIFT	Patients underwent LIFT with bone marrow mononuclear cell injection
LIFT	LIFT	Patients underwent LIFT proecdure

Primary Outcome Measures

Name	Time	Method
Number of patients with complete healing of anal fistula as assessed by clinical examination	6 months	Healing is defined as complete epithelization of the anal wound with absence of fistula tract

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt