Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329862
Status:
TERMINATED
Last Update Posted:
2011-11-15
First Post:
2006-05-23
Brief Title:
Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy
Sponsor:
Central Carolina Surgery PA
Organization:
Central Carolina Surgery PA
Study Overview
Official Title:
Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study size reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Laparoscopic Adjustable Gastric Banding LAGB is a gold standard in the surgical treatment of morbid obesity We hypothesize that the addition of truncal vagotomy cutting of nerves to the stomach will produce greater weight loss and better reduction of co-morbidities diseases caused by or aggravated by morbid obesity than LAGB alone 25 patients will be enrolled and outcomes compared to LAGB historical controls over a post-operative period of 24 months
Detailed Description:
The patients will receive standard laparoscopic adjustable gastric banding treatment as well as truncal vagotomy The vagus nerves will be cut just below the diaphragm using the same access ports that are used during the laparoscopic adjustable gastric banding During the surgical procedure the first fifteen patients will also receive a dose of Baclofen a vagus nerve stimulant and an endoscopy at the end of the procedure during which congo red dye will sprayed within the stomach The Baclofen and endoscopy are used to ensure that all branches of the vagus nerve have been cut If after 15 complete vagotomies are verified by the above testing then the use of Baclofen and endoscopy will be abandoned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None