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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014