Comparison of the Outcomes and Complications of Two transection techniques (Crush-Clamp versus Ultrasonic Dissection) for Hepatic resection in Patients with Hepatic Mass
Comparison of the Outcomes and Complications of Two transection techniques (Crush-Clamp versus Ultrasonic Dissection) for Hepatic resection in Patients with Hepatic Mass in Golestan Hospital
Design
This clinical trial has a control group, with parallel groups, double-blind and random. Patient and data analyzer are not aware of the techniques of surgery. In the control group, patients underwent hepatectomy using crush-clamp. The intervention group underwent Ultrasonic dissection.
Settings and conduct
In this double blind study, patient and data analyzer have no information about surgical technique. The study is being conducted at Golestan Hospital in Ahvaz. As the type of tumor and hepatectomy have a effect on the complications and outcome, we try to identify the two groups in terms of tumor type and hepatectomy type. After selecting the procedure, from the start of operation, all variables including operative time, hepatectomy time, bleeding rate, intraoperative and postoperative blood gases changes, intraoperative and postoperative urine output, postoperative liver enzyme profiles, The patient's INR is recorded postoperatively and compared with each other. The amount of daily discharge and color of the patient's drain is also recorded. If the patient dies, the cause is stated. Patients will be ultrasound on day 3 and 30 postoperatively and compared for intra-abdominal abscess. Patients will be followed for 30 days after discharge and the results will be analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
Patients undergoing hepatectomy are included in the study.
If the patient is not satisfied, he will not be included in the study.
Intervention groups
In the control group, patients underwent hepatectomy using crush-clamp.
The intervention group underwent Ultrasonic dissection.
Main outcome variables
operation time؛ hepatectomy time؛ bleeding rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191016045130N1
Registration date:2019-11-15, 1398/08/24
Registration timing:registered_while_recruiting
Last update:2019-11-15, 1398/08/24
Update count:0
Registration date
2019-11-15, 1398/08/24
Registrant information
Name
Parisa Naviyafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
naviyafar.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Outcomes and Complications of Two transection techniques (Crush-Clamp versus Ultrasonic Dissection) for Hepatic resection in Patients with Hepatic Mass
Public title
Comparison of the Outcomes and Complications of Two transection techniques (Crush-Clamp versus Ultrasonic Dissection) for Hepatic resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are supposed to be hepatectomy
Exclusion criteria:
Patient dissatisfaction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly divided into two groups according to the Random permutations method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the data analyzer are not aware of the techniques of surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.AJUMS.REC.1398.268
Health conditions studied
1
Description of health condition studied
Hepatic failure
ICD-10 code
K72
ICD-10 code description
Hepatic failure, not elsewhere classified
Primary outcomes
1
Description
Operation time
Timepoint
In operation
Method of measurement
By watch
2
Description
Hepatectomy time
Timepoint
In operation
Method of measurement
By watch
3
Description
Bleeding rate
Timepoint
In operation
Method of measurement
By measuring the suction
Secondary outcomes
1
Description
ABG changes
Timepoint
During and after surgery
Method of measurement
Laboratory test
2
Description
Urine output
Timepoint
During and after surgery
Method of measurement
By checking the urine bag
3
Description
Liver enzymes profile
Timepoint
2, 3 and 5 day after surgery
Method of measurement
Laboratory test
4
Description
Patient INR
Timepoint
1, 2, 3 and 4 day after surgery
Method of measurement
Laboratory test
Intervention groups
1
Description
Intervention group: Patients will undergo a hepatectomy by ultrasonic incision.
Category
Treatment - Surgery
2
Description
Control group: Patients will undergo a hepatectomy by crush- clamp.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Meisam Moezzi
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
33118- 61357
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
golestanhospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor in Research Affairs, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Blv
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 7543
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
U-98060
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor in Research Affairs, Ahvaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Parisa Naviyafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3336 7543
Email
naviyafar.p@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Bahreini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
33118 -61357
Phone
+98 61 3374 3001
Email
bahreini-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Paris anaviyafar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3336 7543
Email
Naviyafar.p@ajums.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