A clinical trial comparing the severity of abdominal pain after gallbladder removal from umbilical and subxiphoid ports in patients with symptomatic gallstone
To compare abdominal pain severity after gallstone removal from umbilical and subxiphoid ports in patients with symptomatic gallstone
Design
In this study, 76 eligible patients with symptomatic gallstone referring to Afzalipour medical center of Kerman were incorporated. Participants were randomly assigned into two intervention groups, and each participant was assigned a code.
Settings and conduct
The intervention in this double-blind study was performed in two groups in Afzalipour cre center in Kerman. Both groups underwent general anesthesia followed by laparoscopic cholecystectomy with four ports. In the first intervention group, the gallbladder was removed from the subxiphoid port, which is the conventional site. In the second group, the gallbladder was removed from the umbilical port.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: presence of symptomatic gallstone and elective laparoscopic cholecystectomy surgery conducted in Afzalipour Care Center of Kerman. Major exclusion criteria: patients taking psychotropic drugs, including hypnotic and sedative drugs for any reason; epilepsy patients treated with antiepileptic therapy; and postoperative surgical complications, including wound bleeding and infection.
Intervention groups
Intervention group 1 (subxiphoid port): after the patient underwent general anesthesia, the gallbladder was removed from the subxiphoid port. Intervention group 2 (umbilical port): after the patient underwent general anesthesia, the gallbladder was removed from the umbilical port.
Main outcome variables
Postoperative abdominal pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033099N10
Registration date:2019-10-31, 1398/08/09
Registration timing:retrospective
Last update:2019-10-31, 1398/08/09
Update count:0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
2017-12-21, 1396/09/30
Scientific title
A clinical trial comparing the severity of abdominal pain after gallbladder removal from umbilical and subxiphoid ports in patients with symptomatic gallstone
Public title
Abdominal pain after gallbladder removal
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years
Presence of symptomatic gallstone
Elective laparoscopic cholecystectomy surgery conducted in Afzalipour Care Center of Kerman
Informed consent for participation in the study
Exclusion criteria:
Patients taking psychotropic drugs, including hypnotic and sedative drugs for any reason
Epilepsy patients treated with antiepileptic therapy
Patients who received pain relief for any reason
Patients who had postoperative surgical complications, including wound bleeding and infection
Acute cholecystitis patients whose pain initiated 72 hours earlier and did not respond well to medical treatment, thereby undergoing laparoscopic cholecystectomy
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
After the patients were recruited, they were assigned a code. Using the table of random numbers, the researcher allocated them to intervention group one or two.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study aim and procedure were explained to the patients. However, it remained untold as to which port to be used for the removal of their gallbladder. Patients and those who collected the data were blinded to the gallbladder removal port.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Haft Bagh Alavi Ave.
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.KMU.ACRS.REC.1396.1129
Health conditions studied
1
Description of health condition studied
Symptomatic gallstone
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Postoperative abdominal pain severity
Timepoint
6 hours, 24 hours and 2 weeks after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (subxiphoid port): after the patient underwent general anesthesia, the gallbladder was removed from the subxiphoid port.
Category
Treatment - Surgery
2
Description
Intervention group 2 (umbilical port): after the patient underwent general anesthesia, the gallbladder was removed from the umbilical port.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Care Center
Full name of responsible person
Dr. Ali Afsharizadeh
Street address
Imam Khomaini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
m.mofidi92@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Ibn Sina Ave.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr Ali Afsharizadeh
Position
General surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
m.mofidi92@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Ali Afsharizadeh
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 4234 0301
Email
m.mofidi92@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3242 0447
Email
roozgar@bums.ac.ir
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
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
when the article extracted from the research project is published and for 6 months
To whom data/document is available
researchers
Under which criteria data/document could be used
research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document