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Minimally Invasive Trocar Placement in Obesity Surgery

This study has been completed.
Sponsor:
Collaborators:
Stryker SA
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00610025
First received: December 26, 2007
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.


Condition Intervention
Obesity
 Procedure: Transgastric access to the abdomen

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Obesity
U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient. [ Time Frame: At surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bacterial contamination analysis; results compared to previous study. [ Time Frame: Surgery ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2007
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery)
 Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Active Comparator: 2
10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery)
 Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Active Comparator: 3
10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
 Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Active Comparator: 4
10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
 Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Active Comparator: 5
10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
 Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Active Comparator: 6
10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified)
 Procedure: Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.

Detailed Description:

Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery

Exclusion Criteria:

  • Lack of consent
  • History of previous gastric surgery
  • Contraindication to upper endoscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610025

Locations
United States, Ohio
The Ohio State University Medical Center/Center for Minimally Invasive Surgery
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jeffrey Hazey
Stryker SA
Natural Orifice Surgery Consortium for Assessment and Research
Investigators
Principal Investigator: Jeffrey W Hazey, MD The Ohio State University Medical Center/Center for Minimally Invasive Surgery
  More Information

No publications provided

Responsible Party: Jeffrey Hazey, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00610025     History of Changes
Other Study ID Numbers: NOTES Trocar Study, Project 60009927, Award GRT00006515, IRB 2007H0045
Study First Received: December 26, 2007
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
NOTES
transgastric endoscopy
obesity surgery
Roux-en-Y surgery

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013