Minimally Invasive Trocar Placement in Obesity Surgery

Jeffrey Hazey

Status: Completed

Conditions: Obesity

Treatments: Procedure: Transgastric access to the abdomen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00610025

Award GRT00006515

NOTES Trocar Study

Project 60009927

IRB 2007H0045

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 6 patient groups

1

Active Comparator group

Description:

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)

Treatment:

Procedure: Transgastric access to the abdomen

2

Active Comparator group

Description:

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)

Treatment:

Procedure: Transgastric access to the abdomen

3

Active Comparator group

Description:

10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)

Treatment:

Procedure: Transgastric access to the abdomen

4

Active Comparator group

Description:

10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)

Treatment:

Procedure: Transgastric access to the abdomen

5

Active Comparator group

Description:

10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)

Treatment:

Procedure: Transgastric access to the abdomen

6

Active Comparator group

Description:

10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified)

Treatment:

Procedure: Transgastric access to the abdomen