Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Tugberk Tok
General Surgeon
Kayseri Training and Research Hospital