NOTES-Assisted Laparoscopic Cholecystectomy Surgery

• Sponsor: USGI Medical (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00486655
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 24.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cholelithiasis; Cholecystitis	Procedure: NOTES-Assisted Cholecystectomy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assisted Laparoscopic Cholecystectomy Surgery
• Study Start Date: May 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Quality of Life [2 weeks]

Secondary Outcome Measures

1. Incidence of complications [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Clinic	Portland	Oregon	United States	97210

Sponsors and Collaborators

• USGI Medical

Investigators

• Principal Investigator: Lee Swanstrom, MD, Oregon Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00486655
• Other Study ID Numbers: LS0701
• First Posted: Jun 14, 2007
• Last Update Posted: Aug 8, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by , ,: Cholecystectomy; NOTES; Transgastric
• Additional relevant MeSH terms: Cholecystitis; Cholelithiasis; Cholecystolithiasis; Gallstones

Study Results

No Results Posted as of Aug 8, 2012