NOTES-Assisted Laparoscopic Cholecystectomy Surgery

USGI Medical

Status: Terminated

Conditions: Cholecystitis; Cholelithiasis

Treatments: Procedure: NOTES-Assisted Cholecystectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486655

LS0701

Details and patient eligibility

About

This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Full description

A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to undergo general anesthesia
• Age >= 18 yrs. of age and <= 85 yrs. of age
• Ability to give informed consent

Exclusion criteria

• Acute cholecystitis
• BMI >= 40
• Contraindicated for EGD
• Presence of common duct stones
• Presence of esophageal stricture
• Altered gastric anatomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)