Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Comparison of anal sphincter distensibility
研究概览
简要总结
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.
The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.
This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.
Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.
No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.
Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.
The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.
Twenty-eight patients will be enrolled in this study over a period of 36 months.
Preoperative assessment will include
- clinical examination
- the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence
- video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.
If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old
- •Patient is not under any type of guardianship
- •Patient has a rectocele > 3 cm during defecography
- •Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month)
- •Patient received information and signed the consent form
- •Patients having social security coverage
排除标准
- •Patient has an asymptomatic rectocele
- •Patient with an enterocele at rest upon defecography, with opacification of the small bowel
- •Faecal incontinence
- •Anal sphincter insufficiency detected by rectal manometry
- •Patient with non-rehabilitated anorectal asynchrony
- •Patient has previously had rectal surgery or pelvic radiotherapy
- •Patient has a anal or rectal lesion, intestinal inflammatory disease
- •Anal or rectal tumor
- •Immunocompromised subjects
- •Positive pregnancy test, by urine
- •Psychological condition which would impair participation in the study
- •Coagulation disorders
- •Patients using anticoagulants
- •Participation in any other device or drug study within 30 days prior to enrollment.
- •Patient cannot read French
- •Patient is under any type of guardianship
研究组 & 干预措施
Surgery
Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system
干预措施: stapled transanal rectal resection (Device)
Surgery
Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system
干预措施: Anal compliance measure with Endoflip system (Device)
结局指标
主要结局
Comparison of anal sphincter distensibility
时间窗: Month 3
Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure. The device used is Endoflip system
次要结局
- Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery(Month 3)
- Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery(Month 3)
- Comparison of radiological data (Anal ultrasound)(Month 3)