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NCT Number: NCT07603635

Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula

This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.

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Key information

Conditions

Anal Fistula Surgery Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Transsphincteric Anal Fistula

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Training and Research Hospital

Kayseri, 38300, Turkey (Türkiye)

About this study

This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.

Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.

The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 75 years
  • Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging
  • Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage
  • Ability and willingness to provide written informed consent
  • Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach

Exclusion criteria

  • Previous definitive surgery for perianal fistula other than abscess drainage
  • Perianal Crohn disease
  • Horseshoe fistula
  • Colorectal cancer
  • Malnutrition
  • Recurrent anal fistula
  • Previous radiotherapy or chemotherapy
  • Chronic medication use that could impair wound healing, such as steroids or colchicine
  • Refusal or inability to provide written informed consent

Treatment and study plan

Standard LIFT

Procedure

Standard ligation of the intersphincteric fistula tract was performed. The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.

Modified LIFT via a Lateral Approach

Procedure

Modified LIFT via a lateral approach was performed. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed.

Primary outcomes

  1. Wound Healing Time

    Time frame: Up to 12 weeks after surgery

    Time from surgery to complete clinical epithelialization of the perianal wound without discharge.

Secondary outcomes

  1. Early Recurrence or Persistence of Anal Fistula

    Time frame: Postoperative weeks 1, 4, 8, and 12

    Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up.

  2. Postoperative Pain Assessed Using the Visual Analog Scale

    Time frame: Postoperative weeks 1, 4, 8, and 12

    Postoperative pain will be assessed using the Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.

  3. Fecal Continence Assessed Using the Wexner Fecal Incontinence Score

    Time frame: Postoperative weeks 1, 4, 8, and 12

    Fecal continence will be assessed using the Wexner Fecal Incontinence Score. The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate worse continence.

Sponsors and collaborators

Lead sponsor

Tugberk Tok

Other Gov

Registry information

Official study title

Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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