Early Outcomes of Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) Compared With Ligation of the Intersphincteric Fistula Tract (LIFT) in High Anal Fistula: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assessment of failure rate of IFOC and LIFT procedures
研究概览
简要总结
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. The study purpose will be explained, and informed consent will be obtained from eligible participants. A detailed medical history and routine preoperative assessment will be conducted.
Clinical evaluation will include identification of the internal and external openings, assessment of discharge, and continence status using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to evaluate the fistula tract and its relation to the sphincter complex.
Patients will be randomly allocated into two equal groups (1:1 ratio) using a computer-generated sequence:
Group A: Undergo LIFT procedure Group B: Undergo IFOC procedure Both procedures will be performed as per standard surgical techniques. Postoperatively, patients will start oral fluids after 2 hours and resume a normal diet as tolerated. Discharge is planned on the first postoperative day unless otherwise indicated. Follow-up will be conducted at 1 week, 2 weeks, 1 month, and monthly thereafter for at least 6 months to assess healing and detect complications, including recurrence.
详细描述
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. High anal fistula is defined as involvement of more than one-third of the sphincter complex. Patients with inflammatory bowel disease, low anal fistula, fistula secondary to colorectal malignancy, pre-existing fecal incontinence, or previous levator ani muscle injury will be excluded. The study will be explained to eligible patients, and informed consent will be obtained.
All patients will undergo detailed history taking and clinical examination, including identification of internal and external openings, assessment of discharge, and evaluation of continence using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to define the fistulous tract and its relation to the sphincter complex.
Patients will be randomly allocated into two equal groups using a computer-generated sequence. Group A will undergo the LIFT procedure, while Group B will undergo the IFOC procedure.
In the LIFT procedure, the fistulous tract will be identified, dissected in the intersphincteric plane, ligated at two points, and divided. The external opening will be curetted and left for drainage. In the IFOC procedure, the tract will be identified and opened intra-anally, followed by curettage and closure of the internal opening with absorbable sutures, with drainage of the external tract.
Postoperatively, patients will resume oral intake within hours after surgery and are usually discharged on the first postoperative day. Follow-up will be conducted at regular intervals for at least six months to assess healing, continence, complications, and recurrence.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high anal fistula from both gender
排除标准
- •Patient with preoperative fecal incontinence
- •Fistula secondary to colorectal malignancy
- •Patients with inflammatory bowel disease
- •Fistula secondary to trauma or radiation
- •Low anal fistula
研究组 & 干预措施
Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)
Patient with high anal fistula will be treated with Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)
干预措施: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) (Procedure)
Ligation of the Intersphincteric Fistula Tract (LIFT)
patient with high anal fistula will be treated with Ligation of the Intersphincteric Fistula Tract (LIFT)
干预措施: Ligation of the Intersphincteric Fistula Tract (LIFT) (Procedure)
结局指标
主要结局
Assessment of failure rate of IFOC and LIFT procedures
时间窗: Up to 6 months postoperatively
Assessment of failure rate, defined as failure of healing or recurrence of anal fistula during the follow-up period, in both treatment groups. (Healing is defined as: Complete closure of the external opening, Absence of pus discharge , Absence of local pain or inflammation and No detectable tract on examination ) (Recurrence is defined as: Reappearance of discharge from the previous external opening after initial healing, or development of a new fistulous opening at or near the surgical site.)
次要结局
- Operative time(During surgery)
- surgical site infection(Up to 6 months postoperatively)
- Time for wound Healing(Up to 6 months postoperatively)
- Postoperative bleeding(Up to 6 months postoperatively)
- Postoperative fecal incontinence(Up to 6 months postoperatively)
- Time to return to normal activity(Up to 6 months postoperatively)
- Postoperative urine retention(Within 48 hours postoperatively)
- Pain intensity(At day 1 and day 7 postoperatively)
研究者
Ahmed Mohamed Abdelaal
Lecturer
Cairo University