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临床试验/NCT05041608
NCT05041608Enrolling By Invitation不适用

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
5,000
试验地点
1
主要终点
Efficacy of procedure

研究概览

简要总结

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

详细描述

Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Subjects undergoing Endoscopic Surgery

排除标准

  • •Subjects not undergoing Endoscopic Surgery

结局指标

主要结局

Efficacy of procedure

时间窗: Upto 1 year

Technical and clinical success rate

Safety of procedure

时间窗: Upto 1 year

Type, frequency and intensity of adverse events

次要结局

  • Quality of Life after procedure(Upto 1 year)

研究者

发起方
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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