Comparison of a new synthetic, absorbable sealant with current surgical methods to prevent bleeding and air leak in general surgery and thoracic operations
Clinical goals of this study include evaluation of a new synthetic, absorbable sealant to prevent bleeding and air leak without using sutures in patients undergoing general surgery and thoracic operations and instruction to the general surgery residents concerning the utilization of a new hemostatic method.
Inclusion Criteria of this study consist of abdominal trauma patients with Grade I &II splenic, liver and renal injuries and patients undergoing elective surgical operations such as cholecystectomy or thoracotomy. Patients undergoing neurosurgery and vascular operations in addition to pregnant and lactating women are excluded from the study.
During a one-year period 30 patients, according to inclusion criteria, will be entered in the study and intra-operative and postoperative amount of bleeding and/or air leak in addition to the time of hemostasis and the number of possible failed cases will be documented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201028588N1
Registration date:2012-05-29, 1391/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-29, 1391/03/09
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of a new synthetic, absorbable sealant with current surgical methods to prevent bleeding and air leak in general surgery and thoracic operations
Public title
Evaluation of a new material to prevent bleeding and air leaks in general and thoracic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Abdominal trauma patients with Grade I &II splenic and liver injuries؛ Hemostasis following partial splenectomy؛ Hemostasis after liver mass resection (eg:metastasis)
Liver bed hemostasis following cholecystectomy ؛Hemostasis of Grade I & II renal injuries ؛Hemostasis following partial nephrectomy for superficial tumors؛Aerostasis after lung Decortication ؛Hemostasis of Grade I lung injury ؛Aerostasis after lung wedge resection
Exclusion Criteria:Neurosurgery operations ؛Vascular operations؛ gastrointestinal anastomosis؛ Patients hemodynamic instability؛ Splaenic, liver and renal injuries greater than Grade II؛ Pregnant and lactating women undergoing surgery
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
Other injuries of lung؛ Malignant neoplasm of kidney؛ except renal pelvis؛ Cholelithiasis؛ Malignant neoplasm؛ Liver؛ unspecified؛ Injury of unspecified intra-abdominal organ؛ Other pleural conditions.
Primary outcomes
1
Description
Amount of IntraOperative Bleeding
Timepoint
During the Intervention
Method of measurement
Millilitre
2
Description
Air Leak
Timepoint
During the Intervention
Method of measurement
Observation(Grade I,II,III)
Secondary outcomes
empty
Intervention groups
1
Description
Using a Medical Sponge Intraoperatively
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool-e-Akram Hospital
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.
Full name of responsible person
Dr.Mohammad Vaziri
Position
Fellowship of Thoracic Surgery
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center,Hazrat Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Iran
Phone
+98 21 6655 5447
Fax
Email
dr_m_vaziri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.