Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Bowel QoL
研究概览
简要总结
Effective treatment for constipation is a real clinical challenge especially in patients with severe symptoms. Dietary measures (bulking agents) and drugs (laxatives, stool softeners, suppositories and enemas etc.) have limited efficacy in severe cases. If conservative measures do not help, surgical therapies might be considered. Subsequently, antegrade enemas through percutaneous colonic catheter were introduced as a less invasive option for treating severe constipation. The cecostomy has been performed laparoscopically, percutaneously, and with the laparoscopic-assisted percutaneous endoscopic cecostomy (LAPEC) technique. This approach allows patients to deliver osmotic agents to the right colon.The procedure has been demonstrated to be safe and effective in young adults and pediatrics. To date, there are only few studies evaluating the safety and efficacy of the LAPEC procedure in adults and all have retrospective profile. The aim of this prospective study is to compare short and long-term efficacy and safety of LAPEC in patients with severe constipation. Symptoms of defecation will be the main outcome criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Supportive Care
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory (> 6 months) and severe (based on a =KESS >11) and non-invasive therapeutic approaches, including an enhanced fiber diet, lifestyle changes, laxatives, and biofeedback failed.
- •Slow transit constipation
- •Anorectal malformation
- •Mixed constipation (combination of outlet obstruction and slow transit)
- •Hirschsprung's disease
- •Idiopathic constipation ineffective to standard treatment
- •Cauda equine syndrome
- •Combination of spina bifida and tethered cord
- •Colonic neuropathy.
- •Persons 18 years or older at the time of signing the informed consent
- •Signed informed consent
排除标准
- •Non-LAPEC cecostomy procedure
- •Pre-existing severe electrolyte imbalance
- •Chronic high rectal tone
- •Advanced liver cirrhosis (Child B or Child C)
- •Pregnancy or puerperium
- •Advanced colorectal cancer
- •Presence of ventriculoperitoneal shunt
- •Colonic disease or surgery that might impact safety of percutaneous colostomy tube placement (right hemicolectomy, IC resection, previous apendicostomy) and confirmed inflammatory bowel disease
- •Any other condition, which in the opinion of the investigator would interfere with study requirements
结局指标
主要结局
Change in Bowel QoL
时间窗: Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement
Main outcome is the proportion of patients with treatment success at 3 and 6 months after the catheter placement. Treatment success is defined as a decrease of Quality of Life symptoms score at least 50% to a baseline values. To assess constipation severity the Knowles Eccersley Scott Symptom (KESS) before and throughout the study will be completed. The KESS is an 11-item tool for diagnosis of constipation. The KESS uses four- to five-point Likert scales that are scored on an unweighted linear integer scale. Total scores can range from 0 (no symptoms) to 39 (high symptom severity).
次要结局
- Change in Bowel QoL(3 months, 6 months, 12 months, 24 months)
- Transit time(At 3 and 12 month after PEC placement)
- Frequency and Severity of Abdominal Pain(Data collection will start following consent and procedural training and will be collected daily from day 1 for the duration of the study, an expected average of 12 weeks)
- Flush Administration Time(Data collection will start with the first flush administered following discharge from the hospital and will be collected with every subsequent flush through completion of the study, an expected average of 48 weeks)
- Removal rate(12 months)
- Flush volume(Data collection will start with the first flush administered following discharge from the hospital and will be collected with every subsequent flush through completion of the study, an expected average of 48 weeks)
- Procedural adverse event(1 month)
- Long-term adverse events(3, 6, 12, 24 months)