The aim was to compare incidence of trocar site hernia between two groups, a group with repair of fascial and without fascia repair.
Design
Patients are randomly divided into two treatment groups closure of fascia and without closure of fascia by matching BMI and sex variables.
Settings and conduct
In this clinical trial study patients undergoing Laparoscopic sleeve gastrectomy in 2019 and 2020 will be enrolled in this study.
Participants/Inclusion and exclusion criteria
In this clinical trial study patients with Laparoscopic sleeve gastrectomy will be included in the study. Exclusion criteria included patient whom wasn't appropriate for laparoscopic surgery, patient with past history of any kind of hernia, indeterminate technique in closing trocar incision, patient who undergo any other laparotomy or laparoscopic surgeries for other reasons after or before the Laparoscopic sleeve gastrectomy, patient whom laparoscopic surgery was converted to open surgery and patient who didn't sign the consent form.
Intervention groups
Treated with closure of fascia and without closure of fascia
Main outcome variables
incidence of Trocar site hernia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160803029181N11
Registration date:2020-06-19, 1399/03/30
Registration timing:retrospective
Last update:2020-06-19, 1399/03/30
Update count:0
Registration date
2020-06-19, 1399/03/30
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
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fascia repair and without fascia repair in incident of Trocar Site Hernia after laparoscopic gastrectomy
Public title
The effect of fascia closure in incident of Trocar Site Hernia in laparoscopic sleeve gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- patients undergoing Laparoscopic sleeve gastrectomy - morbid obesity (BMI more than 40 kg/m2 in healthy people and more than 35 kg/m2 with comorbidity)
Exclusion criteria:
- patient whom wasn't appropriate for laparoscopic surgery - patient with past history of any kind of hernia - indeterminate technique in closing trocar incision - patient who undergo any other laparotomy or laparoscopic surgeries for other reasons after or before the Laparoscopic sleeve gastrectomy - patient whom laparoscopic surgery was converted to open surgery -patient who didn't sign the consent form.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
460
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups with closure of fascia and without by matching body mass index and sex variables.we used a randomization number table for randomization of Patients in two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and analyzers are blind to the study. The form of skin suture was the same in both groups, and the Patients and analyzers did not know what group the patients are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commity of Shahid Beheshti University of Medicasl Sciences
Street address
Daneshju Avenue Velenjak
City
Tehran
Province
Tehran
Postal code
19857174433
Approval date
2019-12-15, 1398/09/24
Ethics committee reference number
IR.SBMU.REC.1398.135
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
trocar site hernia
Timepoint
3,6,9,12 month after surgery
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :Treated with fascia repair at site of trocar(10mm diameter, Ethicon, US, LLC) entrance by 1-0 vicryl suture (Supa, Tehran, Iran) with simple suture
Category
Treatment - Surgery
2
Description
Control group:without fascia repair at site of trocar(10mm diameter) entrance
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nasser Malekpour
Street address
Modarres Hospital;Kaj Sq;Saadat Abad;
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Fax
+98 21 2206 9355
Email
nassermalekpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziai
Street address
Danshju Ave Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4087
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD