Assessment of Comparative of the consequences of laparoscopic cholecystectomy with two surgical methods of right and left abdominal port
Design
A clinical trial with a control group and a parallel group was randomized. Phase 2-3, on 80 patients who were candidates for cholecystectomy with single blinded, was used to randomize the randomized block method.
Settings and conduct
This clinical trial study is performed in Imam Hossein Hospital in Tehran. Patients divide two forty groups of right and left abdominal port.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with symptomatic cholelithiasis and acute and chronic cholecystitis.
Exclusions criteria: pregnancy, morbid obesity, common bile duct stones, Obstructive jaundice, cirrhosis, uncorrectable coagulopathy, previous surgery in the upper abdomen
Intervention groups
laparoscopic cholecystectomy with two surgical methods of right and left abdominal ports
Main outcome variables
Duration of surgery, duration of hospitalization, postoperative pain, change of method to open surgery and complications of postoperative surgery will be evaluated between the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N20
Registration date:2022-01-25, 1400/11/05
Registration timing:prospective
Last update:2022-01-25, 1400/11/05
Update count:0
Registration date
2022-01-25, 1400/11/05
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-14, 1400/11/25
Expected recruitment end date
2022-04-14, 1401/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Comparative of the consequences of laparoscopic cholecystectomy with two surgical methods of right and left abdominal port
Public title
laparoscopic cholecystectomy with two surgical methods of right and left abdominal port
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with symptomatic cholelithiasis and acute and chronic cholesistitis.
Exclusion criteria:
pregnancy
morbid obesity
common bile duct stones
Obstructive jaundices
cirrhosis
uncorrectable coagulopathy
previous surgery in the upper abdomen
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action is repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient will be unaware of the type of intervention performed, so the study is performed as single-blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highwa
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.SBMU.MSP.REC.1400.434
Health conditions studied
1
Description of health condition studied
Calculus of gallbladder with acute cholecystitis
ICD-10 code
k80.0, K8
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
Duration of surgery
Timepoint
from the time the skin was cut until the time it was closed
Method of measurement
recorded by surgeon
2
Description
Hospitalization time
Timepoint
from entrance unit until discharge
Method of measurement
numeration of hospitalization days
3
Description
pain after surgery
Timepoint
48 hours after surgery
Method of measurement
measuring levels of pain using visual analog scale(VAS)
4
Description
postoperative narcotic usage
Timepoint
Continuously recorded and measured at the time of discharge
Method of measurement
Patient record
5
Description
Change method to open surgery
Timepoint
Time of surgery
Method of measurement
recorded by surgeon
Secondary outcomes
1
Description
Nausea and vomiting after surgery
Timepoint
in the first 48 hours after surgery
Method of measurement
subjective, recorded by observer from the questionnaire
2
Description
Medical complications after surgery ( bedding, damage of bile ducts,
Timepoint
After surgery
Method of measurement
based on medical chart
Intervention groups
1
Description
Intervention group: 3 ports laparoscopic in patient with gallstone and colisistit right abdominal.
Category
Treatment - Devices
2
Description
Intervention group: 3 ports laparoscopic in patient with gallstone and colisistit left abdominal.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Majid Samsami
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
samsamimd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
info@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
Majid Samsami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
samsamimd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Samsami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
samsamimd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javad Ali Dosti
Position
General Surgery Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
Javadalidoosti@gmail.com
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