Behavioural Treatment Following Ileo-Anal Pouch Formation:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Colo Rectal Functional Outcome Score (COREFO)
研究概览
简要总结
Multi-centre, assessor-blinded, randomised controlled trial comparing physiotherapist-led behavioural intervention (including pelvic floor muscle training) to standard care, in the management of post-operative ileo-anal pouch patients.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven (documented) history of Ulcerative Colitis or Familial Adenomatous Polyposis
- •Proctocolectomy and awaiting ileo-anal pouch formation or have had ileo-anal pouch created and are waiting for stoma reversal or have had stoma reversal within the last 60 days
排除标准
- •Primary sclerosing cholangitis
- •Significant medical or psychiatric comorbidity that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
- •Clinically significant narcotic or substance abuse that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
- •Recognised eating disorder
- •Non- English speaking or illiterate
- •Pregnancy
- •Current participant in another trial
研究组 & 干预措施
Intervention arm
Pelvic floor and bowel behavioural training programme provided by physiotherapists over 2- 6 sessions within the 6 months following ileostomy closure for patients with an ileo-anal pouch
干预措施: Pelvic floor and bowel behavioural training (Behavioral)
Standard arm
Standard post-operative nursing and medical care provided in hospital clinic
干预措施: Standard arm (Other)
结局指标
主要结局
Colo Rectal Functional Outcome Score (COREFO)
时间窗: 6 and 12 months following ileostomy reversal
Between group comparison of outcome score - total and each of 5 domains
次要结局
- Quality of Life EQ-5D(Baseline,3,6 and 12 months following ileostomy closure)
- Brief Cope(Baseline,3,6 and 12 months following ileostomy closure)
- New General Self-Efficacy Scale(Baseline,3,6 and 12 months following ileostomy closure)
- Hospital Anxiety and Depression Scale (HADs)(Baseline,3,6 and 12 months following ileostomy closure)
- Brief Illness Perception Questionnaire(Baseline,3,6 and 12 months following ileostomy closure)
- Pouch Dysfunction score(1,3,6 and 12 months following ileostomy closure)
- Quality of Life Short-Form 36 (SF-36)(Baseline, 3,6 and 12 months following ileostomy closure)
- Inflammatory Bowel Disease Questionnaire (IBDQ)(Baseline,3,6 and 12 months following ileostomy closure)
研究者
Angela Khera
Senior Clinician Physiotherapist
St Vincent's Hospital Melbourne