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

University Hospitals (UH)

Status: Terminated

Conditions: Malnutrition

Treatments: Procedure: Natural Orifice Translumenal Endoscopic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01119040

09-07-23

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

NOTES PEG Rescue

Experimental group

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.

Treatment:

Procedure: Natural Orifice Translumenal Endoscopic Surgery