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Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Previous bariatric surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    LSG

    BTX-LSG

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    number pf patients developing postoperative gastric leakage

    Secondary Outcome Measures

    percent of patients with excess weight loss

    Full Information

    First Posted
    December 19, 2014
    Last Updated
    December 19, 2014
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02325141
    Brief Title
    Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection
    Official Title
    Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LSG
    Arm Type
    Active Comparator
    Arm Description
    patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter
    Arm Title
    BTX-LSG
    Arm Type
    Active Comparator
    Arm Description
    patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic sleeve gastrectomy
    Intervention Description
    creation of a gastric tube of 100cc using a stapler.
    Primary Outcome Measure Information:
    Title
    number pf patients developing postoperative gastric leakage
    Time Frame
    0ne year
    Secondary Outcome Measure Information:
    Title
    percent of patients with excess weight loss
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Body mass index >40 or >35 with hypertension or DM Exclusion Criteria: Previous bariatric surgery

    12. IPD Sharing Statement

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    Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

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