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OpenTrials
Completed

NCT Number: NCT00610025

Minimally Invasive Trocar Placement in Obesity Surgery

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transgastric access to the abdomen

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Bacterial contamination analysis; results compared to previous study.

    Time frame: Surgery

Sponsors and collaborators

Lead sponsor

Jeffrey Hazey

Other

Collaborators

  • Natural Orifice Surgery Consortium for Assessment and Research
  • Stryker SA

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 7, 2008
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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