High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- LARS score
研究概览
简要总结
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
详细描述
Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.
- •Major LARS (score 30-42).
- •At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.
- •Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-
- •Age≥ 18 years
排除标准
- •Side to end mechanical anastomosis or J-pouch colorectal anastomosis
- •Partial or total intersphincteric resection.
- •Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.
- •Persona history of other colorectal, proctologic or pelvis surgery or disease.
- •Personal history of bariatric surgery.
- •Functioning sacral neurostimulator carriers.
- •Previous use of transanal irrigation systems for LARS treatment
- •Presence of an ostomy.
- •Local or distant rectal cancer recurrence and/or any other active neoplastic disease.
- •Altered cognitive status.
- •Pregnancy and age < 18 years
- •Any other diseases that may alter results of the study.
- •Refusal to sign the informed consent.
结局指标
主要结局
LARS score
时间窗: day 1st, 30th, 60th, 75th, 105th, and 135th.
LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.
次要结局
- Daily bowel movements number (total, day, and night)(recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th))
- Adverse effects related to both treatments.(day 1 to 135.)
- Vaizey score(day 1st, 30th, 60th, 75th, 105th, and 135th.)
- Short Form 36 quality of live questionnaire (SF-36)(day 1st, 30th, 60th, 75th, 105th, and 135th.)
- Satisfaction grade (VAS: 0-10).(day 1st, 30th, 60th, 75th, 105th, and 135th.)
- Preferred treatments(day 135)
研究者
Loris Trenti
Principal Investigator
Hospital Universitari de Bellvitge