LIFT With or Without Injection of BM-MNCs

Mansoura University

Status: Completed

Conditions: Anal Fistula

Treatments: Procedure: LIFT; Procedure: bone marrow mononuclear cell injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05134168

Mansoura2022LIFT

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

LIFT

Active Comparator group

Description:

Patients underwent LIFT proecdure

Treatment:

Procedure: LIFT

LIFT+bone marrow mononuclear cell injection

Active Comparator group

Description:

Patients underwent LIFT with bone marrow mononuclear cell injection

Treatment:

Procedure: LIFT

Procedure: bone marrow mononuclear cell injection