Clinical trial of comparing of two methods of measuring the bypassed bowel based on ″total small bowel length" and "Body Mass Index” on benefits and surgical complications of Laparoscopic Mini Gastric Bypass in morbid obese patients
The purpose of this study is to compare the efficacy and surgical complications of laparoscopic Mini Gastric Bypass (MGB) in morbidly obese patients between two different methods in terms of measuring the bypass bowel length and body mass index. This study is a double blinded randomized clinical trial (Phase II) which is going to run in Obesity Clinic in Rasoul-e-Akram Hospital between 2017 and 2019. Inclusion criteria are morbid obese patients (BMI higher than 40 or higher than 35 along with comorbidities) and patient aged 18-60 years. Patients with history of previous abdominal or bariatric surgery and patients with a small bowel length shorter than 300 centimeters are excluded. One hundred patients will be enrolled the study and randomized into two groups and follows at 1, 3, 6 and 12 months after surgery. Intervention group is measuring the bypassed bowel based on about one third of total small bowel length and control group is measuring the bypassed bowel based on BMI which is the standard procedure. The examined outcomes are weight loss, complications, comorbidities and malnutrition.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612118588N21
Registration date:2017-02-12, 1395/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-12, 1395/11/24
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
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparing of two methods of measuring the bypassed bowel based on ″total small bowel length" and "Body Mass Index” on benefits and surgical complications of Laparoscopic Mini Gastric Bypass in morbid obese patients
Public title
Comparing of benefits and surgical complications of Laparoscopic Mini Gastric Bypass in morbid obese patients by two methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with body mass index more than 40 or more than 35 with one obesity commodities.
Exclusion Criteria: Patients with history of previous abdominal or bariatric surgery and the patients with common channel less than 3 meters.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not 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
2016-12-28, 1395/10/08
Ethics committee reference number
IR.IUMS.REC 1395.95-03-140-28882
Health conditions studied
1
Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity
Primary outcomes
1
Description
weight loss
Timepoint
Before the intervention, one month after the intervention, three months after the intervention, six months after intervention, and twelve months after intervention
Method of measurement
scale
2
Description
comorbidities of obesity
Timepoint
Before the intervention , one month after the intervention, three months after the intervention, six months, and 12 months after interventio
Method of measurement
History, Physical Exam, Lab test
3
Description
malnutrition
Timepoint
one month after the intervention, three months after the intervention, six months, and twelve months after intervention
Method of measurement
Lab Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group after measuring the total small bowel length, almost one third of this length will be bypassed.
Category
Treatment - Surgery
2
Description
control group: In this group length of bypassed bowel is measured based on patient's body mass index.