Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital (NCT05228353) | Clinical Trial Compass
CompletedNot Applicable
Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital
India42,471 participantsStarted 2021-06-01
Plain-language summary
Endoscopy of the upper gastrointestinal tract using fiberoptic endoscopes was introduced in the late 1950s and provided the first opportunity for direct visualization of the esophagus, stomach, and duodenum and colon in vivo. GI Endoscopy is usually considered a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures.There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication including:
* Diagnostic and therapeutic upper gastrointestinal endoscopy,
* Diagnostic and therapeutic colonoscopy,
* Endoscopic retrograde cholangiopancreatography (ERCP),
* Endoscopic Ultrasound (EUS),
* Peroral Endoscopic Myotomy (POEM),
* Enteroscopy (Antegrade, Retrograde or spiral)
* Endoscopic mucosal resection (EMR),
* Endoscopic Submucosal Resection (ESD),
* Submucosal Tunnel Endoscopic Resection (STER)
* Anti- Reflex Mucosal Ablation (ARMA)
* Anti- Reflex Mucosal Resection (ARMS)
* GERD-X
* Endoscopic Sleeve Gastrectomy (ESG)
* Intra-gastric Balloon insertion
Exclusion Criteria:
* Those who are not willing to give the consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital