NCT01119040

Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"

Prospective Evaluation of NOTES PEG "Rescue"

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine: 1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube. 2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods. 3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.

Detailed description

1. 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 2. 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 3. 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 * Mortality

Conditions

• Malnutrition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-05-07
• Last updated: 2015-01-05
• Results posted: 2012-12-03

Locations

1 site across 1 country: United States