Determining bile leak after closing the cystic duct with a hemolock clip in cholecystectomy
Laparoscopic
Design
This study will be a clinical trial, case series. 40 cases of patients who underwent laparoscopic cholecystectomy surgery and a number of hemoloc clips are used to close the cystic duct will be included in the study. Data recorded 24 to 72 hours after cholecystectomy will be evaluated for bile leak and cystic duct patency by MRCP. In addition, during one week after the surgery, the intensity of pain, the possibility of biliary peritonitis up to two weeks after the surgery, and the formation of biloma up to three months after the surgery will be checked.
Settings and conduct
In this study, 40 samples will be selected from among the patients who underwent laparoscopic cholecystectomy surgery in Imam Reza and Imam Khomeini hospitals of Ardabil University of Medical Sciences and a clip was used to close their ducts. Sampling method will be available.
Participants/Inclusion and exclusion criteria
candidate for laparoscopic cholecystectomy
Age range from 30 to 60 years
operated by a surgeon
Willingness to participate in the study
Intervention groups
This study will be a Series Case. 40 cases of patients who underwent laparoscopic cholecystectomy surgery and a number of hemoloc clips are used to close the cystic duct will be included in the study. Data recorded 24 to 72 hours after cholecystectomy will be evaluated for bile leak and cystic duct patency by MRCP. In addition, during one week after the surgery, the intensity of pain, the possibility of biliary peritonitis up to two weeks after the surgery, and the formation of biloma up to three months after the surgery will be checked.
Main outcome variables
Biliary peritonitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100628004256N10
Registration date:2023-09-28, 1402/07/06
Registration timing:prospective
Last update:2023-09-28, 1402/07/06
Update count:0
Registration date
2023-09-28, 1402/07/06
Registrant information
Name
Nasrin Samadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3057
Email address
na.samadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the outcome of bile leakage in the use of one hemolock clip to close the cystic duct in laparoscopic cholecystectomy
Public title
Investigating the outcome of bile leakage in the use of one hemolock clip to close the cystic duct in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidate for laparoscopic cholecystectomy
Age range from 30 to 60 years
operated by a surgeon
Willingness to participate in the study.
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committees of Ardabil University of Medical Sciences
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
IR.ARUMS.REC.1402.109
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
K80-K87, K
ICD-10 code description
Disorders of gallbladder, biliary tract and pancreas, Diseases of peritoneum
Primary outcomes
1
Description
Pain
Timepoint
weeks after cholecystectomy
Method of measurement
Evaluation with a pain virtual scale of 0 to 10
2
Description
Biliary peritonitis
Timepoint
2 weeks after cholecystectomy
Method of measurement
Examination by a surgeon and MRCP
3
Description
Biloma
Timepoint
3 months after cholecystectomy
Method of measurement
Examination by a surgeon and MRCP
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One hemoloc clip will be used to close the cystic duct. 24 to 72 hours after cholecystectomy, bile leak and openness of the cystic duct will be checked by MRCP. In addition, during one week after the surgery, the intensity of pain, the possibility of biliary peritonitis up to two weeks after the surgery, and the formation of biloma up to three months after the surgery will be checked.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ardabil
Full name of responsible person
Dr Saeed Shahi
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Saeed Shahi
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Saeed Shahi
Position
surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Saeed Shahi
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Saeed Shahi
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 914 682 9709
Email
na.samadi@arums.ac.ir
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