Effect Of Stapler Line Reinforcement On Complications Of Laparoscopic Sleeve Gastrectomy. Nowadays Laparoscopic Sleeve Gastrectomy (LSG) is uutilized more often for managemnt and treatment of morbid obesity. However,Despite having significant benefits, it has potential serious conplications.Prevention is the best and cost effective way of controlng these complications although there is controversy among surgeons. Patient will be study with BMI(Body Mass Index) of 40 or more and no history of diabet mellitus and/orbpulmonary Disease. Patient Hypoxia; Hypoalbuminemia will be exclud from study.100 patients were selected and randomly divided into 2 groups; first group underwent Stapler Line Reinforcement and another group had operation without stapler line reinforcemen. We Compared the following complications between the two groups: leaking from operation zone, Bleeding and stenosis that need intervention, And if it worths to spend more time in theater and sedate longer due to stapler line reinforcement.Worth of Longer sedation and operation time due to stapler line reinforcement
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100629181N2
Registration date:2016-12-06, 1395/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-06, 1395/09/16
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Modares clinical development center
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Stapler Line Reinforcement On Complications Of Laparoscopic Sleeve Gastrectomy
Public title
Effect Of Surgical Line Reinforcement On Complications Of Laparoscopic Sleeve Gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:Patient with BMI(Body Mass Index) upon 40
Exclusion Criteria:uncontrolled diabetics,uncontrolled cardiopulmonary disease,untreated psychological condition, hypoxia,hypoalbuminemia.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Avenue, Velenjak,Shahid Beheshti University of medical Science
City
Tehran
Postal code
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IT.SBMU.RETECH.REC.1395.427
Health conditions studied
1
Description of health condition studied
Morbid Obesity
ICD-10 code
E66.8
ICD-10 code description
other obesity
Primary outcomes
1
Description
Decreasing leakage
Timepoint
3th 15th days post operation
Method of measurement
Gastrographin and physical examination
2
Description
Decreasing bleeding
Timepoint
first day after surgery
Method of measurement
Hematocrit and drain output
Secondary outcomes
1
Description
Increasing stenosis
Timepoint
3th day post operation
Method of measurement
Gastrographin study
2
Description
Time consuming
Timepoint
During operation
Method of measurement
Operation time
Intervention groups
1
Description
Intervention:Stapler Line Reinforcement in surgical zone with suture
Category
Prevention
2
Description
Control:staple line without suture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modaress Hospital
Full name of responsible person
Nasser Malekpour Alamdari
Street address
Shahid Modares Hospital, Saadat Abad.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ShahidBeheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Street address
ShahidBeheshti University of Medical Sciences, Aarabi Street,Velenjak.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ShahidBeheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
ShahidBeheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular surgeon Fellowship
Other areas of specialty/work
Street address
ShahidBeheshti University of Medical Sciences,Arabi street,Velenjak.