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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01119040
Recruitment Status : Terminated (Low accrual)
First Posted : May 7, 2010
Results First Posted : December 3, 2012
Last Update Posted : January 5, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Malnutrition Procedure: Natural Orifice Translumenal Endoscopic Surgery

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of NOTES PEG "Rescue"
Study Start Date : November 2007
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119040

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

Responsible Party: Jeffrey Marks, MD, Principal Investigator, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01119040     History of Changes
Other Study ID Numbers: 09-07-23
First Posted: May 7, 2010    Key Record Dates
Results First Posted: December 3, 2012
Last Update Posted: January 5, 2015
Last Verified: December 2014

Keywords provided by Jeffrey Marks, MD, University Hospital Case Medical Center:
Dislodged PEG tube

Additional relevant MeSH terms:
Nutrition Disorders