Objectives: This study aims at comparing multiport sleeve gastrectomy (MPSG) and single-port sleeve gastrectomy (SPSG) in terms of their early results and complications.
Design: Patients who referred to obesity clinic in Shiraz University of Medical Sciences and be candidate for Laparoscopic Sleeve Gastrectomy, assigned in two groups to SPSG (group A) and MPSG (group B).
Setting and conduct: Complications like bleeding, hernia, and internal organ injury and demographic data such as BMI, age, gender, operation time and hospital stay could be measured.
Inclusion criteria: Patients with BMI ≥40 or 35≤ BMI ≤ 40 with comorbidity
Exclusion criteria: Patients with hypertension, sleep apnea, diabetes, history of upper abdominal operation.
Intervention:
In first interventional group: Single port sleeve gastrectomy surgery will be performed
In second interventional group: Multi-port sleeve gastrectomy surgery will be performed
Main outcome measures (variables):bleeding, hernia and internal organ injury
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512229936N12
Registration date:2016-03-07, 1394/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-07, 1394/12/17
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor of research-Shiraz University of Medical Sciences
Expected recruitment start date
2014-08-03, 1393/05/12
Expected recruitment end date
2015-08-03, 1394/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early results and complications in multiport sleeve Gastrectomy and Single port Sleeve Gastrectomy
Public title
Comparison of early results and complications in multiport sleeve Gastrectomy and Single port Sleeve Gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Patients with BMI ≥40 or
35≤ BMI ≤ 40
Exclusion: Patients with hypertension, sleep apnea or diabetes and history of upper abdominal operation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple randomization is mentioned, same number of patients that referred to clinic in one period of time assigned in each group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
14336 - 71348
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
7510
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
Weight loss
Timepoint
Before Surgery
Method of measurement
Examinations and weight of the patient
Secondary outcomes
1
Description
Bleeding
Timepoint
The day of surgery, 1 month, 3 months, 6 months after surgery
Method of measurement
Visits by Physician and nurses
2
Description
Adhesion
Timepoint
The day of surgery, 1 month, 3 months, 6 months after surgery
Method of measurement
Visits by Physician
3
Description
Leakage
Timepoint
The day of surgery, 1 month, 3 months, 6 months after surgery
Method of measurement
Visits by surgeon
4
Description
Infection
Timepoint
The day of surgery, 1 month, 3 months,6 months after surgery
Method of measurement
Visits by surgeon
5
Description
Weight after surgery
Timepoint
The day of surgery, 1 month, 3 months,6 months after surgery
Method of measurement
Visits by surgeon
Intervention groups
1
Description
In first group: Single port sleeve gastrectomy
In Sleeve gastrectomy, a part of stomach removed and it causes decrease of food tolerance and eating. Weight loss occurred and the method differs by ports in abdomen during the surgery.
Category
Treatment - Surgery
2
Description
In second interventional group: Multi-port sleeve gastrectomy surgery will be performed
In Sleeve gastrectomy, a part of stomach removed and it causes decrease of food tolerance and eating. Weight loss occurred and the method differs by ports in abdomen during the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahid Faghihi Hospital
Full name of responsible person
Dr Seyed Vahid Hosseini
Street address
Sahid Faghihi Hospital, Zand street, Shiraz, Iran
City
Shiraz
2
Recruitment center
Name of recruitment center
mother and child hospital
Full name of responsible person
Seyed Vahid Hosseini, Dr
Street address
mother and child hospital, Quran Blvd, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Research of Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi, Dr
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Research of Shiraz 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
Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Hajar Khazraei, Dr
Position
Executive manager of colorectal research center/Associated Professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1453
Fax
Email
hajarkhazraei@gmail.comcolorectal2@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences, SHiraz, Iran
Full name of responsible person
Seyed Vahid Hosseini professor
Position
Professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz University of Medical Sciences, SHiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1453
Fax
Email
hoseiniv@sums.ac.ircolorectal2@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences,Iran, Shiraz
Full name of responsible person
Seyed Ali Hosseini, Dr
Position
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz University of Medical Sciences,Iran, Shiraz
City
Shiraz
Postal code
Phone
+7 136281453
Fax
Email
colorectal2@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)