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Prospective Evaluation of NOTES PEG "Rescue"

2014-08-27 03:13:53 | BioPortfolio

Summary

The purpose of this study is to determine:

1. Utility of urgent upper endoscopy in setting of dislodges PEG tube

2. Feasibility of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods

3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.

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 RBC 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

Conditions

Malnutrition

Intervention

Natural Orifice Translumenal Endoscopic Surgery

Location

University Hospitals Case Medical Center
Cleveland
Ohio
United States
44106

Status

Recruiting

Source

University Hospitals of Cleveland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:53-0400

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