Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- Efficacy of procedure
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects undergoing Endoscopic Surgery
Exclusion Criteria
- •Subjects not undergoing Endoscopic Surgery
Outcomes
Primary Outcomes
Efficacy of procedure
Time Frame: Upto 1 year
Technical and clinical success rate
Safety of procedure
Time Frame: Upto 1 year
Type, frequency and intensity of adverse events
Secondary Outcomes
- Quality of Life after procedure(Upto 1 year)