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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05134168

Enrollment

Registered

2021-11-24

Start date

2019-06-01

Completion date

2021-11-01

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

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.

Interventions

PROCEDUREbone 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

PROCEDURELIFT

The fistula tract is ligated in the intersphincteric space

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026