Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2019-06-01
2021-11-01
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LIFT
Patients underwent LIFT proecdure
LIFT
The fistula tract is ligated in the intersphincteric space
LIFT+bone marrow mononuclear cell injection
Patients underwent LIFT with bone marrow mononuclear cell injection
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
LIFT
The fistula tract is ligated in the intersphincteric space
Interventions
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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
LIFT
The fistula tract is ligated in the intersphincteric space
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Immunocompromised patients
* Patients with previous pelvic radiotherapy
* Pregnant women
* Patients with ASA (American society of anesthesiologists) III or higher.
18 Years
75 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Sameh Emile
Associate professor of surgery
Locations
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Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Other Identifiers
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Mansoura2022LIFT
Identifier Type: -
Identifier Source: org_study_id