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

Malnutrition Clinical Trial

Official title: Prospective Evaluation of NOTES PEG "Rescue"

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

• NCT number: NCT01119040
• Study type: Interventional
• Source: University Hospital Case Medical Center
• Status: Terminated
• Phase: N/A
• Start date: November 2007
• Completion date: July 2010