Clinical trial NCT01119040: Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"
Official title: Prospective Evaluation of NOTES PEG "Rescue"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malnutrition
Keywords: Dislodged PEG tube
NOTES
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-05-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
timeFrame: 30 day follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Jeffrey Marks, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.