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

NCT04377542 | Unknown

• 1 other identifier: Mansoura152020
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

LIFT

ACTIVE COMPARATOR

Ligation of intersphincteric fistula tract

Procedure: LIFT

Parks

ACTIVE COMPARATOR

Modified Parks technique

Procedure: Parks

Seton

ACTIVE COMPARATOR

Two-stage seton placement

Procedure: Seton

Interventions

LIFT PROCEDURE

Ligation of the fistula tract in the intersphincteric plane

LIFT

Parks PROCEDURE

Modified Parks fistulotomy with complete internal anal sphincterotomy

Parks

Seton PROCEDURE

Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles

Seton

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

Parks, Recreational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sports and Recreational Facilities; Non-Medical Public and Private Facilities

Study Officials

• Sameh H Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 30, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)