NCT02325141

Brief Summary

Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

December 19, 2014

Last Update Submit

December 19, 2014

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • number pf patients developing postoperative gastric leakage

    0ne year

Secondary Outcomes (1)

  • percent of patients with excess weight loss

    one year

Study Arms (2)

LSG

ACTIVE COMPARATOR

patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter

Procedure: laparoscopic sleeve gastrectomy

BTX-LSG

ACTIVE COMPARATOR

patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter

Procedure: laparoscopic sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

creation of a gastric tube of 100cc using a stapler.

BTX-LSGLSG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index \>40 or \>35 with hypertension or DM

You may not qualify if:

  • Previous bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of surgery

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 24, 2014

Record last verified: 2014-12