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LIFT With or Without Injection of BM-MNCs

Primary Purpose

Anal Fistula

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

bone marrow mononuclear cell injection

LIFT

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LIFT

LIFT+bone marrow mononuclear cell injection

Arm Description

Patients underwent LIFT proecdure

Patients underwent LIFT with bone marrow mononuclear cell injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05134168

First Posted

November 12, 2021

Last Updated

November 23, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05134168

Brief Title

LIFT With or Without Injection of BM-MNCs

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIFT

Arm Type

Active Comparator

Arm Description

Patients underwent LIFT proecdure

Arm Title

LIFT+bone marrow mononuclear cell injection

Arm Type

Active Comparator

Arm Description

Patients underwent LIFT with bone marrow mononuclear cell injection

Intervention Type

Procedure

Intervention Name(s)

bone marrow mononuclear cell injection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

LIFT

Intervention Description

The fistula tract is ligated in the intersphincteric space

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Mansoura university hospital

City

Mansourah

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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LIFT With or Without Injection of BM-MNCs

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