Comparing the effect of splenectomy with ligasure and conventional splenectomy (silk and suture) in traumatic patients referred to Emam Reza Hospital, Birjand, 2012-13
The main objective of this investigation is the comparison of the intraoperative hemorrhage and operation time between two groups of patients (Control and investigation group). All admitted patients with splenic injury (sample size 80 people) were included. Demographic data (gender and age) will be collected by a questionnaire. After planning for splenectomy, patients were divided into two groups randomly. All of the operations will have done by one surgeon. In control group (39 patients) patients will undergo splenectomy using conventional method with silk suture ligation of splenic vasculature. In investigation group (41 patients), a Ligasure vascular sealing system will be used for ligation of the splenic vein and artery. The operation time will be measured from the start of anesthesia process up to the end of recovery. Intraoperative hemorrhage will be measured by collecting the volume of blood in suction bag. The volume of blood that exit from drain will be considered as post-operative hemorrhage. Inclusion criteria are hemodynamic instability and third and more degree of spleen damage in CT scan. Exclusion criteria are BMI>30 and unwillingness to participate in the study. Intervention is method of splenectomy that will be done by means of LigaSure in the intervention group and silk suture in the control group. Main outcome measures (variables) are operation time and intraoperative hemorrhage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112148375N2
Registration date:2012-09-08, 1391/06/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-08, 1391/06/18
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of splenectomy with ligasure and conventional splenectomy (silk and suture) in traumatic patients referred to Emam Reza Hospital, Birjand, 2012-13
Public title
LigaSure application in Splenectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Multiple trauma patients with splenic injury who need splenectomy; Third degree and more splenic injury on abdominal CT scan staging.
exclusion criteria: Patients who do not have agreement to participate in study; Body Mass Index (BMI) more than 30.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a single blind study and after planning for splenectomy and taking the consent from, patients will be divided into two groups randomly and will not be aware of their treatment method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Avenue
City
Birjand
Postal code
9717853577
Approval date
2012-02-07, 1390/11/18
Ethics committee reference number
18111390
Health conditions studied
1
Description of health condition studied
Splenic injury after blunt abdominal trauma
ICD-10 code
S36.0
ICD-10 code description
Injury of spleen
Primary outcomes
1
Description
Duration of surgery
Timepoint
During surgery
Method of measurement
Duration of surgery will be measured from the start point to the end of the operation.
2
Description
Intra-operative bleeding volume
Timepoint
During surgery
Method of measurement
Volume of intraoperative bleeding which collected in the suction (ml) and the number of bloody gauzes (each gauze 10 cc and long gauze 60 cc) will be measured.
Secondary outcomes
1
Description
Post-operative bleeding
Timepoint
Every 6 hours to discharge
Method of measurement
The blood volume collected in drain's bag (cc)
Intervention groups
1
Description
Intervention group: Splenectomy with Ligasure
Category
Treatment - Surgery
2
Description
Control group: Conventional splenectomy using sutures
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Educational Hospital
Full name of responsible person
Dr Seyed Amirkazem Vejdan
Street address
Surgery Ward, Emam Reza Educational Hospital, Taleghani Avenue
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Vice-Chancellor for Research , Birjand University of Medical Sciences, Ghafari Avenue
City
Birjand
Grant name
Grant code / Reference number
664
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Surgery ward, Emam Reza Educational Hospital, Birjand University of Medical Sciences
Full name of responsible person
Dr Ghodrat Allah Naseh
Position
General Surgeon/ Chief of surgery ward
Other areas of specialty/work
Street address
Surgery ward, Emam Reza Educational Hospital, Taleghani street
City
Birjand
Postal code
Phone
+98 56 1222 2300
Fax
Email
Nasehghodrat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Surgery ward, Emam Reza Educational Hospital, Birjand University of Medical Sciences
Full name of responsible person
Dr Seyed Amirkazem Vejdan
Position
General Surgeon
Other areas of specialty/work
Street address
Surgery ward, Emam Reza Educational Hospital, Taleghani street
City
Birjand
Postal code
Phone
+98 56 1222 2300
Fax
Email
vejdan_sa@yahoo.com
Web page address
www.surgeryonweb.com
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee, Birjand University of Medical Sciences
Full name of responsible person
Seyed Alireza Javadinia
Position
Medical Student
Other areas of specialty/work
Street address
Student Research Committee, Birjand University of Medical Sciences, Ghafari Avenue
City
Birjand
Postal code
Phone
+98 56 1222 2300
Fax
Email
sar.javadinia@bums.ac.ir
Web page address
sarjavadinia@blogfa.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)