RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton

Anal Fistula Clinical Trial

Official title:

Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04377542
• Other study ID #: Mansoura152020
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.

This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: June 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females

Exclusion Criteria:

• Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)

• Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.

• Patients on long-acting steroids or immunosuppressive drugs.

• Patients with fecal incontinence (FI)

• Patients with previous anorectal operations including surgery for previous anal fistula.

• Patients with ASA score (American society of anesthesiologists) of III and higher

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• LIFT
Ligation of the fistula tract in the intersphincteric plane
• Parks
Modified Parks fistulotomy with complete internal anal sphincterotomy
• Seton
Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of anal fistula	complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.	6 months after surgery