Minimally Invasive Trocar Placement in Obesity Surgery

February 11, 2013 updated by: Jeffrey Hazey

Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center/Center for Minimally Invasive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacterial contamination analysis; results compared to previous study.
Time Frame: Surgery
Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeffrey Hazey

Collaborators

Natural Orifice Surgery Consortium for Assessment and Research
Stryker SA

Investigators

  • Principal Investigator: Jeffrey W Hazey, MD, The Ohio State University Medical Center/Center for Minimally Invasive Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOTES Trocar Study
  • Project 60009927
  • Award GRT00006515
  • IRB 2007H0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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