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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04377542

Enrollment

Registered

2020-05-06

Start date

2019-01-01

Completion date

2020-06-30

Last updated

2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

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.

Interventions

PROCEDURELIFT

Ligation of the fistula tract in the intersphincteric plane

PROCEDUREParks

Modified Parks fistulotomy with complete internal anal sphincterotomy

PROCEDURESeton

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026