Comparison of recurrence and postoperative complications between open and laparoscopic surgical procedures ventral hernia repair
Design
This study will be conducted as a randomized, double-blind clinical trial.
Settings and conduct
This study is about comparison of recurrence and postoperative complications between open and laparoscopic surgical procedures ventral hernia repair in Imam Khomeini Hospital in Kermanshah. In this study, the patients and the peoples who measuring the variables would be unaware of the presence of patients in the first group and or in the second groups. Only the surgeon aware about grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages between 18 and 65 years old - Have ventral hernia surgery by laparoscopic and open method
Exit criteria : Emergency hernia - Factors that increase intra-abdominal pressure, such as COPD, too much obesity, BPH and pregnancy
Intervention groups
Intervention: Surgical type
Intervention group1: Surgical patients with laparoscopic surgery
Intervention group2: Surgical patients with open surgery
Main outcome variables
Infection, hematoma, skin necrosis and seroma caused by laparoscopy and open surgery
Duration of hospitalization after laparoscopic and open surgery
Time to feel pain after laparoscopy and open surgery
Time to return to work after laparoscopic and open surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100609004141N4
Registration date:2019-07-18, 1398/04/27
Registration timing:prospective
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
ezatollah sadeghi
Name of organization / entity
kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6325
Email address
dr.makhsosy@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of recurrence and postoperative complications between open and laparoscopic surgical procedures ventral hernia repair
Public title
Comparison of recurrence and postoperative complications between open and laparoscopic surgical procedures ventral hernia repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 and 65 years old
Have ventral hernia surgery by laparoscopic method
Have ventral hernia surgery by open method
Exclusion criteria:
Emergency hernia
Factors that increase intra-abdominal pressure, such as COPD
Too much obesity
BPH
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The assignment of patients to each group will be applied based on randomization block to control the effect of age and sex. And so on the proportion of sex (women and men) and age (under 40, 40 years old and more) will be approximately the same in the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients and the peoples how measuring the variables would be unaware of the presence of patients in the first group and or in the second groups. Only the surgeon aware about grouping, after of ending the evoluation of necessary variables, groups of each person will be spesified in cheklist, based on coding system.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
IR.KUMS.REC.1398.122
Health conditions studied
1
Description of health condition studied
Ventral hernia
ICD-10 code
K43.9
ICD-10 code description
Ventral hernia without obstruction or gangrene
Primary outcomes
1
Description
Infection caused by laparoscopy and open surgery
Timepoint
1: 6 weeks after surgery 2: 6 ± 15 months after surgery
Method of measurement
By observing the patient
2
Description
Hematoma caused by laparoscopy and open surgery
Timepoint
1: 6 weeks after surgery 2: 6 ± 15 months after surgery
Method of measurement
By observing the patient
3
Description
Skin necrosis caused by laparoscopy and open surgery
Timepoint
1: 6 weeks after surgery 2: 6 ± 15 months after surgery
Method of measurement
By observing the patient
4
Description
Seroma caused by laparoscopy and open surgery
Timepoint
1: 6 weeks after surgery 2: 6 ± 15 months after surgery
Method of measurement
By observing the patient
5
Description
Duration of hospitalization after laparoscopic and open surgery
Timepoint
After surgery until discharge
Method of measurement
Duration of patient admission in hours, in hospital after surgery
6
Description
Time to feel pain after laparoscopy and open surgery
Timepoint
Immediately after surgery
Method of measurement
The number of minutes someone has pain after the surgery
7
Description
Time to return to work after laparoscopic and open surgery
Timepoint
Immediately after surgery
Method of measurement
The number of hours that a person will need to return to his head after surgery.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is the type of surgery. Intervention group1: Patients who are eligible for inclusion in the study are included in the study and without knowing , they are undergoing laparoscopic surgery. Laparoscopic surgery is a type of surgery in which, a thin, luminous tube is placed inside a cut in the abdomen or pelvis so that the surgeon can see the patient's part without breaking the member and then heal it.
Category
Treatment - Surgery
2
Description
The intervention is the type of surgery. Intervention group2: Patients who are eligible for inclusion in the study are included in the study and without knowing , they are undergoing open surgery. Open surgery is a type of surgical procedure in which the skin and muscles are completely cracked and opened so that the surgeon can see the patient's part with the eye and then heal it.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital in Kermanshah
Full name of responsible person
Dr Behnam Reza Makhsosy
Street address
Imam Khomeini Hospital in Kermanshah, Naghliye avenue, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
ihosp@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behnam Reza Makhsosy
Position
Surgeon of Imam Khomeini Hospital in Kermanshah
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital in Kermanshah, Naghliye avenue , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
dr.makhsosy@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behnam Reza Makhsosy
Position
Surgeon of Imam Khomeini Hospital in Kermanshah
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital in Kermanshah, Naghliye avenue , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
dr.makhsosy@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sharmin Rahmani
Position
Researcher of Research Unit, Imam Khomeini Hospital, Kermanshah
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Imam Khomeini hospital in Kermanshah, Naghliye avenue, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 2049
Email
sh.rahmani90@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the samples being unidentifiable, data is publishable .
When the data will become available and for how long
The access period; Starts 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who try to help science can use data.
From where data/document is obtainable
Expert of Research Unit of Imam Khomeini Hospital in Kermanshah , Sharman Rahmani , sh.rahmani90@yahoo.com
What processes are involved for a request to access data/document
1- Send a request to sh.rahmani90@yahoo.com 2. The purpose of the data request, stated clearly. 3- If confirmed by the main executor, immediately proceed.