Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue" (PEGRescue)
The purpose of this study is to determine:
- Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
- Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
- Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Evaluation of NOTES PEG "Rescue"|
- Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods. [ Time Frame: 30 day follow-up ] [ Designated as safety issue: Yes ]Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
|Study Start Date:||November 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: NOTES PEG Rescue
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.
Procedure: Natural Orifice Translumenal Endoscopic Surgery
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.
Other Name: NOTES
Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:
- Percentage of Open vs. Closed Gastrotomy upon urgent endoscopy
- Presence of Incidental Pathology noted on Endoscopy
- Complications of Urgent Endoscopy
- Time of Procedure
Technical Feasibility of the NOTES procedure determined by:
- Number of Successful/Failed PEG Placements
- Number of Patients Requiring intra-operative conversion to laparotomy or laparoscopic procedure
- Time to Complete Procedure
- Presence or absence of post-procedural contrast extravasation on completion contrast radiographic study
Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:
- Number of Patients Requiring Subsequent Medical or Surgical Treatment for Intra-Abdominal Abscess
- Number of Patients Requiring Subsequent Medical or Surgical Wound Infection within 30 post-op days
- Post-Operative CT or Operative Findings consistent with abscess confirmed by culture positive drainage, aspiration
- Intra-Operative or Post-Operative Red Blood Cell Transfusion
- Length of Stay
- Antibiotics > 24h Post-Op
- 30 day Re-Admission
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119040
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Jeffrey Marks, MD||University Hospital Case Medical Center|