Fistulectomy With Primary Sphincter Reconstruction vs. Muco-muscular Endorectal Advancement Flap in the Treatment of High Transsphincteric Anal Fistulas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Incontinence rate
研究概览
简要总结
The optimal method of surgical treatment of complex anorectal fistulas has not been found yet.
The aim of this study is to compare two techniques in treatment of high anorectal fistulas. This study purpose to demonstrate that the fistulectomy with dissection from 1/3 to 2/3 of the height of the sphincter complex with primary suturing is technically simpler, equally effective and safe in comparison with muco-muscular endorectal advancement flap.
详细描述
Anorectal fistula is a common proctological disease with prevalence between 8.6 and 10 per 100,000 population. Surgical treatment of complex anorectal fistulas has two main objectives: preventing the recurrence of the disease and preserving the anal continence. The optimal principle of management of patients with anorectal fistulas includes a comprehensive preoperative examination with the definition of the architectonics of the fistulous tract, the identification of the internal fistulous opening, the elimination of additional tracts and cavities.
Many methods are used for high anorectal fistula's treatment, but the optimal strategy has not been found yet.
Nowadays, the conventional sphincter-preserving operation for the treatment of complex anorectal fistulas is advancement rectal flap. In addition, plastic with a full-thickness flap in comparison with a mucosal flap was associated with less reccurence rate (10% and 40% respectively), and was accompanied by manifestation of incontinence symptoms, increased with the thickness of the flap.
About 20 years ago, in an attempt to reduce high level of incontinence, the primary reconstruction of sphincters after fistulotomy was proposed; however, this technique is still debated.
According to reports, dissection of more than 1/3 of the sphincter increases the incidence of postoperative incontinence. However, fistulectomy with primary suturing of the sphincter defect allows to improve the function of anal continence and is recommended for patients with initial incontinence after previous surgical interventions.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's consent to participate in the study
- •Patient's consent for surgery
- •High transsphincteric anorectal fistula, involving from 1/3 to 2/3 of the height of the sphincter according to the both MRI and intraoperative revision
- •Cryptoglandular fistulas
- •The absence of incontinence before the operation in accordance with the classification CCFF-IS
- •Preoperative MR-diagnostics before the operation
排除标准
- •Refuse of the patient to participate in the study.
- •Low transsphincteric (involving less than 1/3 of the height of the sphincter according to MRI), intersphincteric, extrasphincteric fistula of the rectum.
- •Recurrent fistula.
- •Rectovaginal or rectourethral fistula.
- •Anal incontinence (Appendix 2).
- •Inflammatory bowel disease (confirmed endoscopically and morphologically).
- •Patients with immunodepression (i.e. HIV)
- •The presence of an acute purulent process in the perianal area.
- •Anterior anorectal fistula in female.
- •The inability to perform MRI of the pelvic organs.
结局指标
主要结局
Incontinence rate
时间窗: 1 day - 1 year
The frequency of incontinence after the operation in accordance with the classification CCFF-IS (Cleveland Clinic Florida Faecal Incontinence Score). 0 points - total continence, 24 points - complete incontinence.
次要结局
- Recurrence rate(1 day - 1 year)
- Overall quality of life(assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year)
- Pain intencity(1 day, 7 day, 14 day, 30 day)
- Wound healing(30 day - 90 day)