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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedNovember 24, 2021
November 1, 2021
2.3 years
November 12, 2021
November 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
LIFT
ACTIVE COMPARATORPatients underwent LIFT proecdure
LIFT+bone marrow mononuclear cell injection
ACTIVE COMPARATORPatients underwent LIFT with bone marrow mononuclear cell injection
Interventions
bone marrow mononuclear cells were injected in the intersphincteric space and around the internal opening after ligation and division of the tract
The fistula tract is ligated in the intersphincteric space
Eligibility Criteria
You may qualify if:
- Adult patients of either gender presented with cryptoglandular trans-sphincteric anal fistula
You may not qualify if:
- Patients with secondary anal fistula
- Immunocompromised patients
- Patients with previous pelvic radiotherapy
- Pregnant women
- Patients with ASA (American society of anesthesiologists) III or higher.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of surgery
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 24, 2021
Study Start
June 1, 2019
Primary Completion
September 1, 2021
Study Completion
November 1, 2021
Last Updated
November 24, 2021
Record last verified: 2021-11