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Low accrual
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The purpose of this study is to determine:
Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:
Technical Feasibility of the NOTES procedure determined by:
Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOTES PEG Rescue | Experimental | A new way of performing surgery is called Natural Orifice Translumenal Endoscopic Surgery, or NOTES, for short. NOTES may allow surgeons to perform abdominal surgery without any skin incisions. By using natural openings in the body, like the mouth, surgeons can enter the stomach with a tube instead of the traditional method of making an incision in the skin of the abdomen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Orifice Translumenal Endoscopic Surgery | Procedure | Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods. | Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery. | 30 day follow-up |
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Inclusion Criteria: Patients must meet ALL of the following criteria
Exclusion Criteria: Patients must not meet ANY of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Marks, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17404790 | Result | Marks JM, Ponsky JL, Pearl JP, McGee MF. PEG "Rescue": a practical NOTES technique. Surg Endosc. 2007 May;21(5):816-9. doi: 10.1007/s00464-007-9361-2. Epub 2007 Apr 3. |
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Patients were recruited at University Hospitals Case medical Center between November 2007 and July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | NOTES "PEG Rescue" | Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peg Rescue | Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods. | Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery. | Only 1 subject due to low accrual | Posted | Number | participants | 30 day follow-up |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NOTES PEG Rescue | Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes. |
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Study terminated early due to difficulty with patient accrual due to lack of patient population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Marks, MD/Principal Investigator | University Hospitals Case Medical Center | 216-983-4930 | jeffrey.marks@UHhospitals.org |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| number of days to assure leak-proof gastrocutaneous tract | Following initial placement of a PEG tube, a variable number of days is required to assure a leak-proof gastrocutaneous tract formed between the adherent stomach serosa and the parietal peritoneum of the anterior wall. In well-nourished, healthy individuals free of wound-healing impairment, a robust gastrotomy track is typically formed within 2 to 4 weeks. For PEG tubes dislodged in the first two weeks post-operatively, the risk of an incompletely formed gastrocutaneous fistula track prompts concern for intra-abdominal leakage from gastrotomy. | Number | Days |
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| 0 |
| 1 |
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| 1 |
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