跳至主要内容
临床试验/NCT04169152
NCT04169152招募中不适用

Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study

Faming Zhang1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Recurrence rate

研究概览

简要总结

Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.

详细描述

CAES is an innovative endoscopic sclerotherapy procedure which is different from traditional method. Firstly, the cap added to the front of colonoscope can fully expose the operating field. Secondly, before or during the opportunity of CAES, endoscopist can perform endoscopic differentiation diagnosis (such as tumors, inflammatory bowel disease and others induced hematochezia), endoscopic therapy within lower-gut based on the same colon preparation, thus saving patients' medical cost, physical and mental pain. The last but not least, specially designed length of endoscopic injection needle (eg.10-20 mm) was used in CAES could be helpful for accurately controlling the injection angle, direction, depth under direct vision and to avoid iatrogenic injury due to ectopic injection.The core value of CAES for internal hemorrhoids and rectal prolapse is to provide precise therapy, reduce the iatrogenic injuries, avoid pain during and after therapy. Our pilot studies demonstrated that CAES based on long injection needle is an effective, safe, convenient operation technique. 100% of participants underwent CAES showed sustained clinical efficacy within the 3-month follow-up, with no severe or obvious complications related to CAES. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse need to be confirmed by further large sample real world studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
  • Patients with bowel preparation.

排除标准

  • History of anoscopic/endoscopic sclerotherapy.
  • Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
  • Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
  • Inflammatory bowel disease.
  • Full-thickness rectal prolapse through the anus.
  • Acute diarrhea in the past 24 hours.
  • Hypertensive with uncontrolled blood pressure.
  • Cerebrovascular accident.
  • Blood coagulation dysfunction.
  • Pregnant women.
  • Mental disorders.
  • Decompensated cirrhosis.

结局指标

主要结局

Recurrence rate

时间窗: 1st week to 24th week

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

  • severe adverse events (SAEs) severe adverse events (SAEs) severe adverse events (SAEs) Severe adverse events (SAEs)(1st day, 1st week, 2nd week and 24th week)
  • Participants' attitudes toward CAES(24th week)
  • Symptom severity score(1day and 24 weeks)
  • Improvement rate(1st day, 1st week, 2nd week and 24th week)
  • Three-level EuroQol five dimensions (ED-5Q) health scale scores(24th week)
  • Adverse events (AEs)(1st day, 1st week, 2nd week and 24th week)
  • Failure rate(1st day, 1st week, 2nd week and 24th week)

研究者

发起方
Faming Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Faming Zhang

Professor, Gastroenterology

The Second Hospital of Nanjing Medical University

研究点 (1)

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