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

NCT ID: NCT01119040

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-07-31

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

Conditions

Malnutrition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Natural Orifice Translumenal Endoscopic Surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

NOTES

Eligibility Criteria

Inclusion 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Marks, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Marks, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17404790 (View on PubMed)

Other Identifiers

09-07-23

Identifier Type: -

Identifier Source: org_study_id