The ReVo Study (REctal Irrigation VOlume Study - 'Low Versus High Volume Irrigation - Optimising Rectal Irrigation Volume in Evacuatory Dysfunction'; A Randomised Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Patient Assessment of Constipation - Quality of Life questionnaire (PAC-QOL)
研究概览
简要总结
Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support.
Two systems of rectal irrigation are available based on volume delivered, low and high volume. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology.
Therefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum.
This trial/research aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum.
The main questions it aims to answer are:
- if one type of rectal irrigation is superior to the other
- whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound
- assess the acceptability and response rates to rectal irrigation.
Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day.
Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.
详细描述
Rectal irrigation(RI) is introducing warm tap water through the anal canal into the rectum to initiate defaecation. It is recommended that rectal irrigation be considered in patients with evacuation disorders refractory to conservative measures and bio-feedback before performing surgery.
RI is provided either as low-volume(LV) or high-volume(HV). It is unknown if one type of RI is superior to the other and whether one type of RI has better outcomes in patients with a particular pathology.
This randomised controlled trial aims to compare outcomes between two types of RI (LV and HV) and assess efficacy and acceptability of RI as a therapy in patients with Chronic constipation (CC) secondary to evacuation disorders (ED).
Primary Objective To compare the impact of LV RI versus HV RI, upon disease-specific quality of life at three months in patients with CC secondary to ED.
Secondary Objectives
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
- Single (Outcomes Assessor)
盲法说明
Participants and clinicians will be aware of treatment allocations. The need to collect data on frequency and volume of irrigation, as well as reasons for discontinuing means that assessor blinding is not possible with respect to these outcomes. However, the statistician involved in the analysis will only receive coded data and therefore will be blinded.
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
- •All adult patients over 18 years who have self-reported problematic constipation secondary to evacuation disorders
- •With symptom onset of more than 6 months
- •Symptoms must meet American College of Gastroenterology definition of constipation which is symptoms including unsatisfactory defecation with either infrequent stools, difficulty in passing stool or both for at least previous 3 months (25)
- •All should have tried and failed conservative management (laxatives, life-style modification and bio-feedback)
- •Patients should also have ability and willingness to give informed consent.
- •Patients or carer should be able to use rectal irrigation
排除标准
- •Patients with
- •Major colorectal resection surgery, pelvic floor surgery to address defaecatory problems such as posterior vaginal repair, STARR, rectopexy and sacral nerve stimulation within last three months
- •Pregnancy
- •Active rectal bleeding
- •Colorectal cancer
- •Complicated diverticular disease or acute diverticulitis
- •Anal or colorectal stenosis
- •Inflammatory bowel disease
- •Undergoing chemotherapy
- •Ischemic colitis
- •Used rectal irrigation in the past one year
研究组 & 干预措施
Low-volume rectal irrigation
This system consists of a small reservoir attached to a cone. Depending on the manufacturer, the reservoir can hold approximately between 110ml and 300ml of water. This reservoir is squeezed to inject water into the rectum. The regime will be such that participants will be asked to use rectal irrigation daily for two weeks. They will be restricted to not use rectal irrigation for more than once in a day. Every day they can use up to 300ml for irrigation. After two weeks participants can then adjust the number of irrigation days per week as well as volume used for irrigation but not exceeding irrigation therapy more than once a day and not more than 300ml per irrigation. Volume and frequency of rectal irrigation will be recorded by participant in participant journal. This will be used to check their compliance and average weekly irrigation sessions and volume used for satisfactory outcome.
干预措施: Rectal Irrigation (Device)
High-volume rectal irrigation
The high-volume irrigation system consists of an irrigation bag connected to a tube. The water flows into the rectum, either by gravity or by using a pump. Some systems use balloon to hold the device in place during irrigation; others require the user to hold it in place. The mechanism of action is the same for all systems. Participants will start irrigation with 300ml and increase this by 100ml every 2 days until satisfactory defaecation is achieved, or the procedure becomes uncomfortable, up to a maximum of 1500ml. Initial frequency of irrigation is the same as for low-volume irrigation: i.e. once daily for two weeks followed by participant adjustment of number of irrigation days per week as well as volume used for irrigation but no more than 1500ml a day. Participants will be restricted to using high-volume irrigation to not more than once a day.
干预措施: Rectal Irrigation (Device)
结局指标
主要结局
Patient Assessment of Constipation - Quality of Life questionnaire (PAC-QOL)
时间窗: At baseline and after three months after using rectal irrigation
PAC-QOL measures health related quality of life in patients with constipation. Lower score reflects better quality of life where it ranges from 0-112
次要结局
- Obstructed Defaecation Syndrome - Score (ODS-S)(At baseline and after three months of using rectal irrigation)
- Patient Assessment of Constipation - Symptoms (PAC-SYM)(At baseline and after three months of using rectal irrigation)
- International Consultation on Incontinence Questionnaire Anal Incontinence Symptoms and Quality of Life Module (ICIQ-B)(At baseline and after three months of using rectal irrigation)