NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Cholecystitis Clinical Trial

Official title:

Assisted Laparoscopic Cholecystectomy Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00486655
• Other study ID #: LS0701
• Status: Terminated
• Phase: N/A
• First received: June 12, 2007
• Last updated: August 7, 2012
• Start date: May 2007
• Est. completion date: June 2007

Study information

• Verified date: August 2012
• Source: USGI Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• NOTES-Assisted Cholecystectomy

Locations

Country	Name	City	State
United States	Oregon Clinic	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
USGI Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		2 weeks
Secondary	Incidence of complications		2 weeks