Feasibility and Impact of a Trimodal Prehabilitation and Rehabilitation Program to Reduce the Predicted Low Anterior Resection Syndrome After Radical Rectal Cancer Treatment. A Non-Randomized Prospective Study Phase II. PRELARS Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Impact of a multimodal package of prehabilitation and rehabilitation in patients with low anterior resection syndrome
研究概览
简要总结
Patients with sphincter saving procedures of rectal cancer usually experience intestinal dysfunction, including difficulty emptying the bowel and faecal incontinence, leading to a detriment in the quality of life. A prospective study is proposed to measure de feasibility and the impact of a continuous care programme for the prevention or reduction of intestinal dysfunction disorders. The intervention lies on prehabilitation and rehabilitation with physiotherapy, biofeedback and neuromodulation, is assisted by a telematic information system (APP for the monitoring of education on physiotherapy and surveillance).
详细描述
-Study design: A single-arm, non-randomized prospective study that will initially evaluate the compliance and feasibility of a prehabilitation and / or functional rehabilitation program in patients with anterior rectal resection with mesorectal excision for rectal cancer. In addition, clinical outcome variables will be obtained to evaluate the possibility of a subsequent efficacy study.
-Patient selection: Participation in this study will be proposed to all consecutive patients with rectal cancer who are expected to perform a low anterior resection of the rectum with mesorectal excision and colorectal anastomosis with or without protective ileostomy, older than 18 years, who give their informed consent, and who can carry out a pelvic floor physiotherapy program and be susceptible to tibial neurostimulation.
Exclusion criteria will be a POLARS score less than 20 (LARS-minor or non-LARS), the existence of residual or distant locoregional disease, the presence of inflammatory bowel disease (IBD), a previous known diagnosis of irritable bowel syndrome (IBS) , patients with intestinal resections other than the rectum, existence of anastomotic complications, or inability to perform pelvic muscle physiotherapy, presence of trophic disorders in the ankles (post-febile syndrome), known diabetic neuropathy, carriers of pacemakers or implantable defibrillators, and with previous SNS or PTNS.
-Interventions:
The package of interventions consists on:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Low anterior resection of the rectum with mesorectal excision and colorectal anastomosis with or without protective ileostomy
- •POLARS score >20
- •over 18 years of age
- •give their informed consent
- •Patients who can perform a pelvic floor physiotherapy program and to tibial nerve stimulation.
排除标准
- •POLARS score less than 20
- •LARS-minor or non-LARS
- •The existence of residual or distant locoregional disease
- •Inflammatory bowel disease (IBD)
- •A previous known diagnosis of irritable bowel syndrome (IBS)
- •Intestinal resections other than the rectum
- •Existence of anastomotic complications
- •Inability to perform pelvic muscle physiotherapy, presence of trophic disorders in the ankles (post-febile syndrome)
- •Known diabetic neuropathy
- •Carriers of pacemakers or implantable defibrillators, and patients who are have previously performed SNS or PTNS.
结局指标
主要结局
Impact of a multimodal package of prehabilitation and rehabilitation in patients with low anterior resection syndrome
时间窗: October 2020- September 2021
To analyze the feasibility of the introduction of a multimodal package of integrated interventions (educational, pelvic floor physiotherapy, biofeedback and posterior tibial neurostimulation-PTNS-) with the objective of reducing the severity of predictable intestinal dysfunction after the radical surgery for rectal cancer, measured by the number of patients that complete the treatment.
次要结局
- Assessment of the improvement of quality of life(October 2020- September 2021)
- Analysis of the correlation between estimated POLARS score and postoperative LARS score(October 2020- September 2021)
- Feasibility of introduction of APP for the education and follow-up(October 2020- September 2021)
- Assessment of the improvement of scores in faecal incontinence,(October 2020- September 2021)
- Assessment of the improvement of pelvic floor contractility(October 2020- September 2021)
研究者
Prof. Jose M Enríquez-Navascués
PhD; Head of service
Hospital Donostia