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

Primary Purpose

Malnutrition

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Natural Orifice Translumenal Endoscopic Surgery
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Dislodged PEG tube, NOTES

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NOTES PEG Rescue

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2010
Last Updated
December 12, 2014
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01119040
Brief Title
Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"
Acronym
PEGRescue
Official Title
Prospective Evaluation of NOTES PEG "Rescue"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Dislodged PEG tube, NOTES

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NOTES PEG Rescue
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Natural Orifice Translumenal Endoscopic Surgery
Other Intervention Name(s)
NOTES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
Description
Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
Time Frame
30 day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Marks, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17404790
Citation
Marks JM, Ponsky JL, Pearl JP, McGee MF. PEG "Rescue": a practical NOTES technique. Surg Endosc. 2007 May;21(5):816-9. doi: 10.1007/s00464-007-9361-2. Epub 2007 Apr 3.
Results Reference
result

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

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