Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a Nationwide Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).
详细描述
Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids.
- •Patients with bowel preparation.
排除标准
- •History of anoscopic/endoscopic sclerotherapy.
- •Patients with acute thrombotic external hemorrhoids.
- •Patients with serious internal hemorrhoids of grade IV.
- •Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease.
- •Patients with acute diarrhea in the past 24 hours.
- •Hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis.
结局指标
主要结局
Recurrence rate
时间窗: 24 weeks
Recurrence rate defined as the proportion of patients with recurrent hemorrhoids at 24 weeks post-CAES, as derived from patients' self-reported answer. Patients will be considered to have recurrent hemorrhoids when any of the following are recorded: (1)"Unchanged or worse compared with before starting treatment" at 24th week as reported by the patient, or (2) seeking repeat CAES treatment, alternative non-surgical/surgical treatments for internal hemorrhoids within 24weeks (except medication treatment), or (3) presence of any symptoms or events that strongly indicated recurrent hemorrhoids among patients not meeting (1) or (2).
次要结局
- Symptoms of anal bleeding(1day, 7days, 14days and 24 weeks)
- Symptoms of anal pain(1day, 7days, 14days and 24 weeks)
- Symptom severity score(1day and 24 weeks)
- Symptoms of prolapse(1day, 7days, 14days and 24 weeks)
- EQ-5D health scale scores(24 weeks)
- Adverse events and serious adverse events(1day, 7days, 14days and 24 weeks)
- Satisfaction degree(24 weeks)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University