Comparative Study Between Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract (LIFT) Technique in Treatment of High Perianal Fistula.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fistula Recurrence Rate
研究概览
简要总结
The goal of this clinical trial is to compare two different surgery methods for treating a complex type of anal fistula. This condition is an abnormal tunnel connecting the inside of the anus to the skin nearby. The main questions the study aims to answer are:
Which surgery has a lower chance of the fistula coming back (recurrence)?
Which surgery has a lower chance of causing problems with bowel control (incontinence) after healing?
Researchers will compare two surgery groups:
Group 1: Fistula Rerouting Technique - a two-step surgery that moves the fistula tract to a safer area before opening it.
Group 2: LIFT Technique - a surgery that ties off and closes the fistula tract from between the anal muscles.
Participants will be randomly assigned by a computer to one of these two surgery groups. This helps ensure the comparison between the two surgeries is fair.
Participants in this study will:
- Have tests before surgery, including an MRI scan, to confirm they have the specific type of fistula being studied.
- Undergo one of the two planned surgical procedures.
- Attend follow-up visits after surgery at 1 week, 2 weeks, 1 month, and 3 months.
- Be checked during these visits for wound healing, pain, infection, and bowel control.
- Have another MRI scan if the fistula is suspected to have come back.
详细描述
This study is a prospective, randomized, controlled, parallel-group surgical trial designed to evaluate and compare the efficacy and functional outcomes of two sphincter-preserving techniques for the management of high perianal fistula: the staged Fistula Rerouting Technique (FRT) and the Ligation of Intersphincteric Fistula Tract (LIFT) procedure.
Background and Rationale:
High perianal fistulas, particularly trans-sphincteric and extrasphincteric types, pose a significant surgical challenge. Traditional fistulotomy carries a high risk of postoperative fecal incontinence due to the division of a substantial portion of the anal sphincter complex. Consequently, sphincter-preserving techniques have been developed. The LIFT procedure, introduced in 2007, achieves closure of the fistula tract via an intersphincteric approach. The FRT, described earlier, employs a staged strategy to physically transpose the fistula tract to a safer intersphincteric plane before its division. While both techniques aim to eradicate the fistula while minimizing injury to the continence mechanism, direct comparative evidence regarding their relative effectiveness, recurrence rates, and impact on postoperative continence is lacking in the literature. This trial aims to fill this evidence gap.
Objectives:
The primary objective is to compare the postoperative recurrence rate of high perianal fistula between the FRT and LIFT groups. The secondary objective is to compare the rate of postoperative fecal incontinence between the two techniques. Additional outcomes include time to wound healing, incidence of surgical site infection, postoperative pain scores, patient-reported quality of life related to incontinence, and time to return to normal activities.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 20-65 years) presenting with a high perianal fistula, defined as:Trans-sphincteric fistula tract traversing the upper two-thirds of the external anal sphincter, Or Extrasphincteric fistula.
- •Patients with recurrent perianal fistula.
- •Ability to provide informed consent.
排除标准
- •Patients with preoperative fecal incontinence (as assessed by the Cleveland Clinic Fecal Incontinence Score).
- •Diagnosis of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- •Pregnant women.
- •Pediatric patients (age < 20 years).
- •Patients with complex, branching fistula tracts.
- •Any contraindication to spinal/general anesthesia or surgery.
研究组 & 干预措施
Fistula Rerouting Technique Group
Participants in this group will undergo a staged Fistula Rerouting procedure. First Stage: The fistulous tract is cored out using diathermy. Dissection is continued until the point where the tract traverses the external anal sphincter. A circumanal incision is made at the anal verge over this point. The intersphincteric space is entered and dissected until the fistulous tract is palpable. The tract is then dissected off the external sphincter via muscle-splitting and transposed into the intersphincteric space. The original defect in the external sphincter is closed with interrupted absorbable sutures. If the transposed tract is too long, its distal portion is excised. A seton may be placed in the new intersphincteric tract to mark it for the second stage, provided this does not risk injury to the mobilized tract.
Second Stage: After complete healing of the first-stage wound (typically several weeks later), a fistulotomy is performed on the new, transposed intersphincteric tract
干预措施: Fistula Rerouting Technique (Procedure)
LIFT Technique Group
Participants in this group will undergo the Ligation of Intersphincteric Fistula Tract (LIFT) procedure.
A curvilinear incision is then made in the intersphincteric groove (the groove between the internal and external anal sphincters) overlying the identified tract.
Dissection proceeds through the intersphincteric plane until the mature, fibrous fistula tract is encountered. The tract is carefully isolated, then divided. Both the internal (toward the anal canal) and external (toward the skin) ends of the divided tract are securely ligated (tied off) with suture material. The infected cryptoglandular tissue surrounding the tract is debrided and removed.
The internal wound (near the anal canal) and the external wound (in the intersphincteric groove) are debrided and left open to heal by secondary intention, ensuring adequate drainage.
干预措施: Ligation of Intersphincteric Fistula Tract (Procedure)
结局指标
主要结局
Fistula Recurrence Rate
时间窗: Within 3 months after the final surgical procedure
The proportion of patients in each group with clinically confirmed recurrence of the perianal fistula within 6 months postoperatively. Recurrence is defined as the reappearance of symptoms (pain, discharge) and/or a confirmed tract on postoperative MRI fistulogram.
Postoperative Fecal Incontinence
时间窗: At 3 months postoperatively
Change in anal continence status assessed using the Cleveland Clinic Fecal Incontinence Score (CCFIS). The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates worse function. Incontinence is defined as a CCFIS ≥ 5.
次要结局
- Time to Complete Wound Healing(From the date of surgery until the date of documented complete healing, assessed up to 3 months)
- Postoperative Wound Infection Rate(Within 6 weeks postoperatively)
- Postoperative Pain(At 1 week and 2 weeks postoperatively)
研究者
Mostafa Mohamed Sedky Ahmed
Lecturer
Cairo University