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

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01119040
First received: May 6, 2010
Last updated: November 3, 2012
Last verified: November 2012
History of Changes
  Purpose

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.

Condition Intervention
Malnutrition
 Procedure: Natural Orifice Translumenal Endoscopic Surgery

Study Type: Interventional
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"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Patients must meet ALL of the following criteria

  • For prospective candidates, an initial attempt to pass a balloon tipped foley catheter through the external cutaneous tract into the stomach will be performed. It will then be followed by radiographic contrast study to evaluate for extravasation of contrast into the peritoneal cavity. If contrast is extravasated, this will be potential candidate for inclusion. If the foley catheter is unable to be passed through the cutaneous tract, that will also be considered someone for inclusion as this patient will still require an operative confirmation of the patency of the gastrotomy.
  • For retrospective candidates, intra-operative confirmation of dislodged tube as reported in the medical record.
  • The patient must demonstrate pre-operative hemodynamic and respiratory stability
  • No overwhelming medical co-morbidities prohibitive of surgery
  • Subject is 18 years of age or older
  • Subject or subject's legal decision-making proxy agrees to participate, fully understands and signs the informed consent form

Exclusion Criteria: Patients must not meet ANY of the following criteria:

  • Esophageal stricture prohibiting passage of an endoscope
  • Any contraindication to surgery
  • Pregnancy or actively breastfeeding women
  • Evidence of active bowel obstruction
  • Synchronous acute abdominal pathology warranting incision-based surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119040

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Jeffrey Marks, MD University Hospital Case Medical Center
  More Information

Publications:

Responsible Party: Jeffrey Marks, MD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01119040     History of Changes
Other Study ID Numbers: 09-07-23
Study First Received: May 6, 2010
Results First Received: October 14, 2010
Last Updated: November 3, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:
Dislodged PEG tube
NOTES

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on June 17, 2013