Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
研究概览
简要总结
The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).
详细描述
Transanal irrigation (TAI) is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS.
The study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with TAI to treatment with glycerol suppositories. Patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with TAI or glycerol suppositories. Primary endpoint will be assessed by the end of week twelve.
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
- 是
入选标准
- •Patients electively treated for rectal cancer with a low anterior resection.
- •Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score >29 at evaluation).
- •At least 3 months after surgery (including reversal of a temporary loop-ileostomy).
- •Age >= 18 years
- •Ability to understand written and spoken language actual for the including site (due to questionnaire validity).
排除标准
- •Former use of TAI
- •Prior systematic use of rectal emptying aids
- •Anastomotic stenosis
- •History of anastomotic leakage
- •Current metastatic disease or local recurrence
- •Ongoing oncological treatment
- •Postoperative radiotherapy for rectal cancer
- •Previous or current cancer in other pelvic organs than the rectum
- •Underlying diarrhoeal disease
- •Inflammatory bowel disease
- •Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.
- •Inability of patient to use TAI
- •Inability and unwillingness to give informed consent
- •Pregnancy or intention to become pregnant during the trial period
研究组 & 干预措施
Transanal irrigation
Participants receiving TAI will irrigate once/day with stepwise volumes; 1. month 150 ml, 2. month 300 ml, and 3. month 500 ml.
干预措施: Qufora Irrisedo Cone System (Device)
Glycerol suppositories
Participants treated with glycerol suppositories will administer one glycerol suppository once/day.
干预措施: Glycerol "OBA" (Drug)
结局指标
主要结局
Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
时间窗: 12 weeks.
MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
次要结局
- Bowel function, change in symptom 2 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.(4, 8, and 12 weeks.)
- Change in activity score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.(4, 8, and 12 weeks.)
- Change in well-being score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.(4, 8, and 12 weeks.)
- Bowel function assessed using the Low Anterior Resection Syndrome (LARS) Score.(4, 8, and 12 weeks.)
- Bowel function assessed using the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) Score.(4, 8, and 12 weeks.)
- Frequency of bowel movements, incontinence episodes (total, passive, and urge), urge episodes, soiling, and daily gas incontinence, incomplete emptying, and average urge time assessed using the Journl A/S application.(Weeks 3-4, weeks 7-8, and weeks 11-12.)
- Fecal incontinence assessed using the St. Mark's Incontinence Score.(4, 8, and 12 weeks.)
- Female urinary function assessed using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS).(12 weeks.)
- Male urinary function assessed using the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).(12 weeks.)
- Female sexual function assessed using The Rectal Cancer Female Sexuality Score.(12 weeks.)
- Male sexual function assessed using the 5-item International Index of Erectile Function (IIEF-5).(12 weeks.)
- Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30.(12 weeks.)
- Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29.(12 weeks.)
- Impact on quality of life and activities assessed using the Journl A/S application.(Weeks 3-4, weeks 7-8, and weeks 11-12.)
- Quality of life and Health economics assessed using the European Quality of Life-5 Dimensions 5-level version questionnaire (EQ-5D-5L).(12 weeks.)
- Health economics assessed using the ICEpop CAPability measure for Adults (ICECAP-A).(12 weeks.)