NCT01789749已完成不适用
Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.
Professor Michael Bourke5 个研究点 分布在 1 个国家目标入组 455 人开始时间: 2013年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 5
- 主要终点
- Endoscopic recurrence
研究概览
简要总结
Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for removal of a colonic polyp >= 20mm in size
- •Able to give informed consent to involvement in trial
排除标准
- •Younger than 18 years of age
- •Highly dependant on medical care
- •Women who are pregnant or may be pregnant.
- •Taken clopidogrel within 7 days
- •Taken warfarin within 5 days
- •Had full therapeutic dose unfractionated heparin within 6 hours
- •Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
- •Known clotting disorder
- •Previous attempt at EMR of the polyp referred for resection
- •Polyp located at the ileo-caecal valve, appendiceal orifice
- •Fully circumferential polyp
- •Incomplete snare resection of the polyp
结局指标
主要结局
Endoscopic recurrence
时间窗: 4-6 months and 18 months
Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up
次要结局
- Perforation during EMR(During index procedure)
- Post EMR bleeding(Post Index procedure)
- Readmission(After index procedure)
- Histologic recurrence(4-6 months and 18 months)
- En bloc resection(Index procedure)
- Duration(Index procedure)
- Number of injections for hemostasis(Index procedure, if post EMR bleeding)
- Location of bleeding vessels(Index procedure, if post EMR bleeding)
- Delayed perforation(After index procedure)
- Snare resections(Index procedure)
- Size/number of bleeding vessels(Index procedure, if post EMR bleeding)
研究者
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District
研究点 (5)
Loading locations...
相似试验
招募中
不适用
Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal PolypsPolyp of ColonColorectal CancerNCT06271941Centre hospitalier de l'Université de Montréal (CHUM)892
Unknown
不适用
Cyanoacrylate to Stop Bleeding After EMR for Large PolypsColorectal PolypNCT04308824Societa Italiana di Chirurgia ColoRettale76
招募中
1 期
Prevention of postoperative endoscopic disease recurrence in Crohn’s disease: a multicentric study that compares the systematic start of biological therapy immediately after an ileocolonic resection with the start of biological therapy in patients with endoscopic recurrence six months after ileocolonic resectioPatients with Crohn's disease undergoing surgery and having at least one risk factor for postoperative recurrence of the disease.MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856CTIS2022-500311-39-00Z Leuven352
尚未招募
Unknown
Prevention of Post-colon ESD Coagulation Syndrome using Polysaccharide Hemostatic PowderNeoplasmsKCT0008728Soon Chun Hyang University Hospital Cheonan196
招募中
不适用
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort StudyColorectal NeoplasmEndoscopic Mucosal ResectionNCT04008407Western Sydney Local Health District391