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| ID | Type | Description | Link |
|---|---|---|---|
| ULIRR024150 | Other Grant/Funding Number | NOSCAR |
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| Name | Class |
|---|---|
| Natural Orifice Surgery Consortium for Assessment and Research | OTHER |
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This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes 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. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to "patch" or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed
Hypothesis: The primary outcome is successful completion of the procedure.
Perforation is the most dangerous complication of gastroduodenal ulcer disease. It accounts for more than 70% of deaths associated with peptic ulcer disease. In addition to age and concomitant disease, intervention related complications are statistically significant predictors of death after hospital stay. Age, time to presentation and comorbidities are not factors that can be influenced. If it would be possible to reduce the impact of procedure related complications or the "second hit", that may lead to decreased morbidity and mortality.
This will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. Endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. Should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Translumenal Omental Patch | Experimental | Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Translumenal Omental Patch | Device | The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair | At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated. | 2 days post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliane Bingener-Casey, MD.S | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23355151 | Result | Bingener J, Loomis EA, Gostout CJ, Zielinski MD, Buttar NS, Song LM, Baron TH, Ghahfarokhi LS, Rajan E. Feasibility of NOTES omental plug repair of perforated peptic ulcers: results from a clinical pilot trial. Surg Endosc. 2013 Jun;27(6):2201-8. doi: 10.1007/s00464-012-2740-3. Epub 2013 Jan 26. |
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Subjects were enrolled between February 2010 and February 2012 at Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endoscopic Translumenal Omental Patch | Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place. Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This includes only those participants for whom ulcer repair was attempted. Participants who were excluded in the operating room (OR) for previously unknown complications were not included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopic Translumenal Omental Patch | Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place. Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair | At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated. | Posted | Number | participants | 2 days post-operation |
|
30 days
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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 | Endoscopic Translumenal Omental Patch | Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place. Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colotomy | Gastrointestinal disorders | Systematic Assessment | Conversion to open procedure was necessary, as a laparoscopic repair was deemed not feasible. After laparotomy, a colotomy in the transverse colon was encountered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juliane Bingener-Casey, M.D. | Mayo Clinic | 507-538-9007 | BingenerCasey.Juliane@mayo.edu |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System 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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| 1 |
| 3 |
| 0 |
| 3 |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Subject has long history of chronic obstructive pulmonary disease (COPD), received upper midline incision for non-study portion of procedure. |
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| D013272 | Stomach Diseases |