A comparison of results of gallbladder extraction through umbilical port versus subxiphoid port in laparoscopic cholecystectomy: A randomized controlled trial
Comparison of results of gallbladder extraction through umbilical port versus subxiphoid port in laparoscopic cholecystectomy.
Design
Randomized control trial with parallel groups , double blind
Settings and conduct
In Shahid Modarres Hospital of Tehran, eligible patients will be assigned in two groups of gallbladder extraction through umbilical and subxiphoid port. All the patients and people in charge of assessment are unaware of gallbladder extraction site during surgery.
Pain level will be assessed in all the patients at 3, 12 and 24 hours after surgery using Visual analogue scale (VAS) also days using analgesic drug will be noted. After one month patients will be evaluated for surgery site infection and satisfaction with the surgery in scale of 1 to 10. After one year patients will be evaluated for hernia.
Participants/Inclusion and exclusion criteria
Inclusion criteria in considered having at least one of the risk factors for incisional hernia including diabetes, age over 60, BMI over 30 and smoking.
Exclusion criteria in this study is open cholecystectomy, gallbladder or intestinal rupture during surgery, previous surgery on midline or upper part of stomach and patient not giving consent.
Intervention groups
Patients would be divided in two groups. In one group gallbladder extraction happens through umbilical port and in other group through subxiphoid port.
Main outcome variables
Average of pain level ; Days using analgesic drugs after surgery; Patient satisfaction level; Surgery site infection; Incisional hernia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161217031440N2
Registration date:2020-03-25, 1399/01/06
Registration timing:registered_while_recruiting
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
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
2019-10-05, 1398/07/13
Expected recruitment end date
2020-10-04, 1399/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of results of gallbladder extraction through umbilical port versus subxiphoid port in laparoscopic cholecystectomy: A randomized controlled trial
Public title
A comparison of results of gallbladder extraction through umbilical port versus subxiphoid port in laparoscopic cholecystectomy: A randomized controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes
Age over 60
BMI more than 30
Smoking
Exclusion criteria:
open cholecystectomy
gallbladder rupture during surgery
Intestinal rupture during surgery
previous surgery on midline or upper part of stomach
patient not giving consent
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
294
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for the study based on inclusion criteria, will be randomly assigned into two groups of different gallbladder extraction site using randomized blocks method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of gallbladder extraction site through their own surgery.
People in charge of the patient assessment are not aware of gallbladder extraction site in each individual patient.
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
193954719
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.868
Health conditions studied
1
Description of health condition studied
Complications after laparoscopic cholecystectomy
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Incisional hernia incidence
Timepoint
One year after surgery
Method of measurement
Asking
Secondary outcomes
1
Description
Pain level after surgery
Timepoint
3, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale
2
Description
Days using analgesic drugs after surgery
Timepoint
One month after surgery
Method of measurement
Days using
3
Description
Surgery site infection incidence
Timepoint
One month after surgery
Method of measurement
Signs such as inflammation and purulent discharge from incision line
4
Description
Patients satisfaction with surgery
Timepoint
One month after surgery
Method of measurement
1 to 10 scale
Intervention groups
1
Description
Intervention group: Extraction of gallbladder through subxiphoid port
Category
Prevention
2
Description
Control group: Extraction of gallbladder through umbilical port
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres medical center
Full name of responsible person
Barmak Gholizadeh
Street address
Shahid Modarres medical center, 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
Assistant 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 scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Barmak Gholizadeh
Position
Assistant 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
Assistant 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