Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Recurrence rate
研究概览
简要总结
Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.
Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.
Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).
The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.
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
- None
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 aged 18 years old or older
- •Diagnosis of simple intersphincteric or transsphincteric fistula
- •Patients able to comply with the study protocol as per investigator criteria
- •Signed and dated informed consent by the patient
- •Absence of any
排除标准
- •Exclusion Criteria:
- •Recurrent anal fistula
- •Suprasphincteric, low subcutaneous fistula
- •Multiple fistulas
- •Posttraumatic fistula
- •Perianal hidradenitis
- •Fistula arises from other than cryptoglandular origin
- •Previous anal surgery except of abscess
- •Inflammatory Bowel Disease
- •History of fecal incontinence
- •Rectal prolapse
- •Malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment
- •HIV infection
- •Pregnancy
- •Participation in another clinical trial less than one month prior to enrolment, or involvement in another trial
研究组 & 干预措施
Rectal advanced mucosal flap
Procedure will be performed in general anesthesia without mechanical bowel preparation. Antibiotic prophylaxis (Metronidazole 1g) will be applied intravenously 60 minutes prior the surgery.
In RAF procedure, internal opening will identified and after infiltration with saline-adrenalin solution (1/100000) the mucosal flap will be mobilized proximally. The external tract and internal opening will be excised and the defect will be sutured. After that, the flap will be advanced from both sides with absorbable suture and overlapped over the internal opening. External openings will be left open.
干预措施: RAF (Procedure)
Ligation of intersphincteric fistula tract
Procedure will be performed in general anesthesia without mechanical bowel preparation. Antibiotic prophylaxis (Metronidazole 1g) will be applied intravenously 60 minutes prior the surgery.
Before LIFT procedure the fistula tract will be identified with small probe. The intersphincteric space will be reached by dissection from small (2-4cm) incision. The fistula tract will be divided and ligated on both sides with Polydioxanone (PDS) suture. The external and internal openings will be left open to drain.
干预措施: LIFT (Procedure)
结局指标
主要结局
Recurrence rate
时间窗: One year
Fistula recurrence will be defined according to AGA (American Gastroenterological Association) criteria as a purulent secretion from external fistula opening followed the compression. Fistula recurrence will be confirmed by evaluation under anesthesia (followed by drainage).
次要结局
- Postoperative pain(14 days)
- Pre- and postoperative continence(One year)
- Postoperative morbidity(One month)
- Quality of life(One year)
研究者
Otakar Sotona
MD
University Hospital Hradec Kralove