Minimally Invasive Trocar Placement in Obesity Surgery

NCT00610025 | Completed

• 4 other identifiers: NOTES Trocar StudyProject 60009927Award GRT00006515IRB 2007H0045
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

NOTES; transgastric endoscopy; obesity surgery; Roux-en-Y surgery

Outcome Measures

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.

  At surgery

Secondary Outcomes (1)

• Bacterial contamination analysis; results compared to previous study.

  Surgery

Study Arms (6)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

3

ACTIVE COMPARATOR

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

4

ACTIVE COMPARATOR

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

5

ACTIVE COMPARATOR

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

6

ACTIVE COMPARATOR

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

Interventions

Transgastric access to the abdomen PROCEDURE

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

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Lack of consent
• History of previous gastric surgery
• Contraindication to upper endoscopy

Sponsors & Collaborators

• Jeffrey Hazey: lead
• Stryker SA: collaborator
• Natural Orifice Surgery Consortium for Assessment and Research: collaborator

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffrey W Hazey, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: February 7, 2008
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

US (1)