NCT05134168

LIFT With or Without Injection of BM-MNCs

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fistula

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-09-01
• Completion: 2021-11-01
• First posted: 2021-11-24
• Last updated: 2021-11-24

Locations

1 site across 1 country: Egypt