(1) Objectives: Our aim in this study is to evaluate the efficacy of Surgicel, TachoSil and Glubran 2 in bleeding control after liver resection. (2) Design: 45 patients from both genders undergoing liver resection in Imam Reza Hospital after qualifying the inclusion and exclusion criteria and obtaining the informed consent, the patients enter the trial process. (3) Setting and conduct: All patients with oozing at the end of the surgery after failure to homeostasis using argon beam coagulator and packing with gauze, will receive Surgicel, TachoSil or Glubran 2 over the resection surface to obtain hemostasis. After hemostasis, drain will be implanted. During the admission, daily drainage volume till the drain extraction and vital signs every 6 hours will be recorded. Patients will be discharged if there is no complication. (4) Participants including major eligibility criteria: Participants will be selected among the patients undergoing liver resection. The key inclusion criteria are to be 18-75 years old and the key exclusion criteria are death during surgery; early closure of the surgery; hepatic insufficiency or coagulopathy after surgery; patients with need for re-operation due to bleeding or bile leakage other than resection site; patients with chronic hepatic disease. (5) Intervention: Using Surgicel, TachoSil or Glubran 2 for bleeding control at the end of liver resection. (6) Main outcome measures: Primary endpoint is bleeding volume after using hemostatic agent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031712834N1
Registration date:2013-05-01, 1392/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-01, 1392/02/11
Registrant information
Name
Mir Salim Seayed Sadeghi
Name of organization / entity
Department of Surgery, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7054
Email address
seayedsadeghim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial comparing the effect of Surgicel, TachoSil and Glubran 2 in controlling bleeding after liver resection
Public title
Randomized clinical trial comparing the effect of different homeostatic agents for controlling homeostasis after hepatic resection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-75 years old; all patients undergoing hepatic resection and have oozing after resection; patients with no coagulation disorders
Exclusion criteria: Death during the surgery;hepatic mass to be none resectable; early closure of the surgery; hepatic insufficiency after surgery; coagulopathy after the surgery; patients with need for re-surgery due to bleeding or bile leakage other than resection site; patients with chronic hepatic disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
91214
Health conditions studied
1
Description of health condition studied
Liver metastasis
ICD-10 code
C78.7
ICD-10 code description
Secondary malignant neoplasm of liver and intrahepatic bile duct
2
Description of health condition studied
Malignant neoplasm of liver and intrahepatic bile ducts
ICD-10 code
C22
ICD-10 code description
Malignant neoplasm of liver and intrahepatic bile ducts
3
Description of health condition studied
Topical homeostatic agents
ICD-10 code
Y56.9
ICD-10 code description
Topical agent, unspecified
4
Description of health condition studied
Other diseases of liver in need of surgery
ICD-10 code
K76.8
ICD-10 code description
Other specified diseases of liver
Primary outcomes
1
Description
Bleeding control
Timepoint
Every 6 hours until 48 hours
Method of measurement
Observation during surgery and evaluation of Hb, INR every 6 hours
Secondary outcomes
1
Description
Complications after oozing control
Timepoint
Days 1, 3, 5,7 after surgery
Method of measurement
Physical examination and paraclinical evaluations
Intervention groups
1
Description
In Surgicel group, Surgicel (a topical cellulose homeostatic agent) in the size of 10*20 cm will be used to control bleeding
Category
Treatment - Drugs
2
Description
In TachoSil group, TachoSil (contains human coagulation factor components: fibrinogen and thrombin) in the size of 4.8*4.8 cm will be used to control bleeding
Category
Treatment - Drugs
3
Description
In Glubran2 group, one Glubran2 glue (N-butyl -2-cyanoacrylate) will bee used to control bleeding.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mir Salim Seayed Sadeghi
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mir Salim Seayed Sadeghi
Position
Surgery resident
Other areas of specialty/work
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Square
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
seayedsadeghim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Surgery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Kakaei
Position
Assistant Professor/ Visceral Transplant Surgeon
Other areas of specialty/work
Street address
Department of surgery, Imam Reza Hospital, Daneshgah Square
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
fkakaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mir Salim Seayed Sadeghi
Position
Surgery resident
Other areas of specialty/work
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Square
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)