Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- LARS score
研究概览
简要总结
The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).
The secondary aims are the evaluation of the following parameters:
- Effect of PTNS on manometric parameters
- Effect of PTNS on quality of life
- Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation
- Safety of PTNS
详细描述
The study is a prospective randomized clinical trial that compares two treatments in patients with LARS:
Arm A: PTNS + conservative treatment (based on predominant symptom) Arm B: only conservative treatment
The study is divided into two phases:
- PRETREATMENT PHASE
The patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to :
- Collection of personal data
- Collection of medical records
- Collection of data relating to the intervention of anterior resection of the rectum
- Verification of the criteria for inclusion / exclusion
- Collection of informed consent
- Administration of the questionnaires European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal 38 (EORTC QLQ-CR38), Faecal incontinence severity index (FISI); Fecal incontinence quality of life questionnaire (FIQL), Obstructed defaecation syndrome (ODS) score questionnaire and Constipation-related quality of life questionnaire (CRQoL)
- Endoanal ultrasound
- Anorectal manometry
- PHASE OF TREATMENT During the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form Bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. Even anorectal manometry will be repeated at the end of treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
- •Age> 18 years;
- •Obtaining informed consent.
排除标准
- •Patients carrying ostomy;
- •Patients with clinical or radiological evidence of local or distant tumor recurrence;
- •Patients suffering from neurological disorders;
- •Patients with Inflammatory Bowel Disease (IBD);
- •Patients who have a pacemaker or defibrillator;
- •Patients taking antiplatelet agents or anticoagulants;
- •Patients unable to follow the procedures of the Protocol or to provide informed consent.
结局指标
主要结局
LARS score
时间窗: 67 weeks
The primary end point is the evaluation of the results of the two interventions in functional terms, by comparing the LARS score calculated first at the end and after 12 months of treatment, according to the following classification: * No LARS: a score between 0 and 20 * LARS mild: score between 21:29 * LARS severe: a score between 30 and 42
次要结局
- EORTC QLQ-C30(67 weeks)
- FISI(67 weeks)
- FIQL(67 weeks)
- ODS SCORE(67 weeks)
- EORTC QLQ-CR38(67 weeks)
- CRQoL(67 weeks)
- functional outcome(67 weeks)
- morbidity(67 weeks)
研究者
Cuicchi Dajana
Dr Dajana Cuicchi MD PhD
IRCCS Azienda Ospedaliero-Universitaria di Bologna