Minimally Invasive Trocar Placement in Obesity Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Transgastric access to the abdomen

• Registration Number: NCT00610025
• Lead Sponsor: Jeffrey Hazey

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-07
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Transgastric access to the abdomen	10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
4	Transgastric access to the abdomen	10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
5	Transgastric access to the abdomen	10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
1	Transgastric access to the abdomen	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)
2	Transgastric access to the abdomen	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)
6	Transgastric access to the abdomen	10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bacterial contamination analysis; results compared to previous study.	Surgery

Trial Locations

Locations (1)

The Ohio State University Medical Center/Center for Minimally Invasive Surgery; 🇺🇸 Columbus, Ohio, United States