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

M

Mansoura University

Status

Unknown

Conditions

Anal Fistula

Treatments

Procedure: LIFT
Procedure: Parks
Procedure: Seton

Study type

Interventional

Funder types

Other

Identifiers

NCT04377542
Mansoura152020

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 3 patient groups

LIFT
Active Comparator group
Description:
Ligation of intersphincteric fistula tract
Treatment:
Procedure: LIFT
Parks
Active Comparator group
Description:
Modified Parks technique
Treatment:
Procedure: Parks
Seton
Active Comparator group
Description:
Two-stage seton placement
Treatment:
Procedure: Seton

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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