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

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

February 11, 2013

Start Date ^ICMJE

July 2007

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Minimally Invasive Trocar Placement in Obesity Surgery

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Procedure: Transgastric access to the abdomen

Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.

Study Arm (s)

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)

Intervention: Procedure: Transgastric access to the abdomen
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)

Intervention: Procedure: Transgastric access to the abdomen
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)

Intervention: Procedure: Transgastric access to the abdomen
Active Comparator: 4
10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)

Intervention: Procedure: Transgastric access to the abdomen
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)

Intervention: Procedure: Transgastric access to the abdomen
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)

Intervention: Procedure: Transgastric access to the abdomen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00610025

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Responsible Party

Jeffrey Hazey, The Ohio State University

Study Sponsor ^ICMJE

Jeffrey Hazey

Collaborators ^ICMJE

Stryker SA
Natural Orifice Surgery Consortium for Assessment and Research

Investigators ^ICMJE

Principal Investigator:

Jeffrey W Hazey, MD

The Ohio State University Medical Center/Center for Minimally Invasive Surgery

Information Provided By

Ohio State University

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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