The aim of this study was to evaluate the effect of oral Inderal reduce bleeding during laparoscopic gastric bypass is. Our study will be done completely randomized, double-blind, multicenter. the study population are patients with severe obesity that have indication for laparascopic gastric bypass surgery (Patients with BMI over 35 with associated complication or with a BMI over 40).the patient with inderal contraindication or any reason their operation will be converted to open surgery is excluded. The sample size for this study is 82 patients that the patients randomly divided into two equal groups are the case group of 40 mg twice a day for one week before surgery to receive either a control group who received a placebo the same way as. The number of bleeding points requiring cautery during surgery by the surgeon measured In stapler lines and recorded then the end of study The outcome of the case and control group are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310108588N17
Registration date:2014-05-20, 1393/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences.
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of propranolol on bleeding from the stapler line during bariatric laparoscopic surgery in morbid obese patients
Public title
Study of effects of oral propranolol on amount bleeding during surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: severe obesity that have indication for laparascopic gastric bypass surgery (Patients with BMI over 35 with associated complication or with a BMI over 40).
Exclusion Criteria: the patient with inderal contraindication or any reason their operation will be converted to open surgery is excluded.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran.
City
Tehran
Postal code
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
20305
Health conditions studied
1
Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
E66.8
Primary outcomes
1
Description
Frequency of bleeding requiring hemostatsis
Timepoint
During of surgery
Method of measurement
based on surgeon's report
Secondary outcomes
empty
Intervention groups
1
Description
case group receive 40 mg inderal (po) twice a day for one week before surgery.
Category
Treatment - Drugs
2
Description
control group received a 40 mg placebo (po) the same way as case group.