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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 22, 2003 |
| Last Updated Date | November 28, 2007 |
| Start Date ICMJE | September 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00061269 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Videoendoscopic Drainage of Infected Pancreatic Collections |
| Official Title ICMJE | |
| Brief Summary | The VARD (Videoendoscopic Assisted Retroperitoneal Drainage) approach as treatment for necrotizing pancreatitis proposes an alternative to standard complicated open abdomen treatment methods. This treatment involves making a small incision and looking inside the abdomen with a videoendoscope. A videoendoscope is an instrument with a small camera and light on the end. It also has an extension tool that the surgeon can use to clean out any dead and infected tissue in the abdomen. This approach may reveal a treatment opportunity with faster recovery potential and shorter hospitalizations for patients with necrotizing pancreatitis. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE | Pancreatitis, Acute Necrotizing |
| Intervention ICMJE | Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD) |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 40 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada |
| Administrative Information | |
| NCT ID ICMJE | NCT00061269 |
| Responsible Party | |
| Study ID Numbers ICMJE | VDIPC |
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Verification Date | November 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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