A Study of the Possibility of the Use of Translumenal Endoscopic Omental Patch for Closure of Perforated Viscus
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT01080326
Sponsor Protocol Number: 08-008389
About this study
The purpose of this study is to see if a new endoscopic approach to the repair of perforated ulcers in the stomach or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Clinical diagnosis of a perforated viscus scheduled to undergo surgical intervention
- Surgical candidate for endoscopic, laparoscopic, or open procedure
- Age > 21
- Signed informed written consent
Exclusion Criteria
- Prior gastric or duodenal surgery
- Prior total abdominal colectomy or transverse colectomy
- Prior omentectomy or omental flaps
- Known perforation site other than stomach or duodenum
- Contra-indications for laparoscopy
- Contraindications for endoscopy
- Upper gastrointestinal anatomy that would preclude endoscopic therapy
- Coagulopathy or thrombocytopenia
- Pregnant
- Age < 21 years
- Prisoners
- If found at surgery to have disease processes other than perforated peptic ulcer disease, will be asked for permission to record data for comparison
More information
Publications
Publications are currently not available