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NCT Number: NCT05134168

LIFT With or Without Injection of BM-MNCs

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.

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bone marrow mononuclear cell injection

Procedure

bone marrow mononuclear cells were injected in the intersphincteric space and around the internal opening after ligation and division of the tract

LIFT

Procedure

The fistula tract is ligated in the intersphincteric space

Primary outcomes

  1. Number of patients with complete healing of anal fistula as assessed by clinical examination

    Time frame: 6 months

    Healing is defined as complete epithelization of the anal wound with absence of fistula tract

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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