Comparison of recurrence rate and pain severity in patients with incisional hernia in open and laparoscopic methods
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 70 patients undergoing incisional hernia surgery
Settings and conduct
This study will be conducted with the aim of comparison of recurrence rate and pain severity in patients with incisional hernia in open and laparoscopic methods on 70 patients attending Shahid Modarres hospital in Tehran city. After inclusion in the study, the patients will be assigned into two groups; open group and laparoscopic group . Pain severity will be assessed using Visual Analogue Scale (VAS) 3 days, one week and 4 weeks after the surgery and recurrence rate will be evaluated by asking the patients and the results will be compared together in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criterion: having incisional hernia with a 3-15 cm diameter
Exclusion criteria: having contraindication for anesthesia; having immunosuppression; having intestinal obstruction
Intervention groups
Intervention group 1: surgery using open method
Intervention group 2: surgery using laparoscopic method
Main outcome variables
Recurrence rate
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161217031440N3
Registration date:2021-10-14, 1400/07/22
Registration timing:prospective
Last update:2021-10-14, 1400/07/22
Update count:0
Registration date
2021-10-14, 1400/07/22
Registrant information
Name
Barmak Gholizadeh
Name of organization / entity
Shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 6403
Email address
b_gholizadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of recurrence rate and pain severity in patients with incisional hernia in open and laparoscopic methods
Public title
Comparison of recurrence rate and pain severity in patients with incisional hernia in open and laparoscopic methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having incisional hernia with a 3-15 cm diameter
Exclusion criteria:
Having contraindication for anesthesia
Having immunosuppression
Having intestinal obstruction
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly assigned into two groups (open and laparoscopic) using a random number table. A random number table containing unrepeated numbers between 1 and 70 is selected and the reading is started from the left. If the number is odd the patient is assigned into open group and if the number is even the patient is assigned into laparoscopic group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the patients is not aware of patients assignment and so is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Third Floor, School of Medicine, Aarabi st., Yaman st., Shahid Chamran hwy.
City
Tehran
Province
Tehran
Postal code
1939547191
Approval date
2020-12-15, 1399/09/25
Ethics committee reference number
IR.SBMU.MSP.REC.1399.468
Health conditions studied
1
Description of health condition studied
Incisional hernia
ICD-10 code
K43.0
ICD-10 code description
Incisional hernia with obstruction, without gangrene
Primary outcomes
1
Description
Recurrence rate
Timepoint
One year after the surgery
Method of measurement
By asking the patient about the recurrence
2
Description
Pain severity
Timepoint
3 days, one week and 4 weeks after the surgery
Method of measurement
By using Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: surgery using open method
Category
Treatment - Surgery
2
Description
Intervention group 2: surgery using laparoscopic method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Barmak Gholizadeh
Street address
Shahid Modarres hospital, Saadat abad st.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zargi
Street address
3rd Floor, School of Medicine, Arabi st., Yaman st., Shahid Chamran hwy.
City
Tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2243 9781
Email
Mpajouhesh@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
Barmak Gholizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres hospital, Saadat abad
City
Tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2298 6403
Fax
+98 21 2298 6403
Email
b_gholizadeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Barmak Gholizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres hospital, Saadat Abad st.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Barmak Gholizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres hospital, Saadat Abad st.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available