Assessment of the effect of Vasopressin injection on decreasing time of surgery and need to electrooagulation for hemostasis during laparascopic cystectomy of patients refered to Zanan Hospital because of endometriomas
The aim of this prospective study is to assess the effect of vasopressin in reducing time of surgery and need for coagulation for hemostasis during laparascopic cystectomy for endometrioma. The inclusion criteria are unilateral ovarian endometrioma(4-7 centimeters) and age 18-35years old. The exclusion criteria are prior ovarian surgery and usage of oral contraceptive before surgery. According to these criteria 14 female randomly would be put inside 2 seperate groups of 7 persons;first group undergoes laparascopic cystectomy with hydrodissection with normal saline and second group undergoes laparascopic cystectomy with hydrodissection with normal saline plus vasopressin. All the surgerys will be done by an experienced surgen. In the case group, 3 milliliter (0.3 units) diluted vasopressin( 200 folds)will be injected to the border of cyst wall and ovarian healthy tisuue for hydrodissection. Ovarian reserve will be measured by sonography to assess antral follicle count and serum follicual stimulating hormone before and 2 regular menstural cycles after surgery in the early proliferative phase of menstural cycle (days 3-6) .During operation,if needed electrocoagulation bipolar (35 watt) will be used to achieve hemostasis.The film of surgery will be reviewed for checking the operation time,and the number of electrocoagulation used. All patients will be assessed bleeding by checking the hemoglubin before and 72 hours after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012512262N1
Registration date:2013-04-05, 1392/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-05, 1392/01/16
Registrant information
Name
Mina Akrami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 0002
Email address
minaakrami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-03, 1391/02/14
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Vasopressin injection on decreasing time of surgery and need to electrooagulation for hemostasis during laparascopic cystectomy of patients refered to Zanan Hospital because of endometriomas
Public title
The effect of Vasopressin on decreasing time of surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:female;18-35 years old; a unilateral ovarian endometrioma; regular menstrual cycles
exclusion criteria : female younger than 18;female older than 35;bilateral ovarian cyst;irregular menstural cycles; prior ovarian surgery ;usage of oral contraceptive pills before surgery;diagnosis of malignancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Science
Street address
Tehran University of Medical Science, Poursina Ave, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-01-13, 1391/10/24
Ethics committee reference number
91/د/130/2628
Health conditions studied
1
Description of health condition studied
Ovarian Endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
operation time
Timepoint
from the begining of dissection of the cyst wall till the complete dissection
Method of measurement
seconds
2
Description
electrocagulation to achieve hemostasis
Timepoint
during operation
Method of measurement
counting the number of it in the film of surgery
Secondary outcomes
1
Description
ovarian reserve
Timepoint
before and 2 months after surgery
Method of measurement
antral follicules by sonography
2
Description
bleeding rate
Timepoint
before and 72 houres later than surgery
Method of measurement
hemoglubin (mg/dl)
Intervention groups
1
Description
In case group,before the dissection of cyst wall ,3 mililiters containing 0.3 units diluted vasopressin of an ampule of vasopressin named (Hypress) which contains 20 units of vasopressin and diluted 200 times by adding 200 mililiters normal salin will be injected in the space between cyst wall and ovary by the specific needle,the injection will be in one place near the grater vessels. Then, 50-70 mililiters normal saline will be injected in multiple points . The cyst wall will be sent for pathological evaluation after stripping.Then the cyst`s bed would be assessed for bleeding and if needed electrocoagulation would be used for hemostasis
Category
Treatment - Surgery
2
Description
In control group,before the dissection of cyst wall , 50-70 mililiters of normal saline will be injected in multiple points in the space between cyst wall and ovary by the specific needle,the. Then, The cyst wall will be sent for pathological evaluation after stripping.Then the cyst`s bed would be assessed for bleeding and if needed electrocoagulation would be used for hemostasis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Great Women Hospital
Full name of responsible person
Dr Mina Akrami
Street address
The Great Women Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science,
Full name of responsible person
Dr.Akbar Fotuhi
Street address
Tehran University of Medical Science,Vice Chancellor of Research
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 Science,
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
Tehran University of Medical Science
Full name of responsible person
Dr Marzie Ghafarnejhad
Position
Assistant Professor
Other areas of specialty/work
Street address
The Great Women Hospital, North Nejatolahi St, Krimkhane Zand Aven, Valliasr Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8890 0002
Fax
+98 21 8891 5959
Email
ghafarin2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Marzie Ghafarnejhad
Position
Assistant Professor
Other areas of specialty/work
Street address
The Great Women Hospital, North Nejatolahi St, Krimkhane Zand Aven, Valliasr Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8890 0002
Fax
+98 21 8891 5959
Email
ghafarin2@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Mina Akrami
Position
Obstetric & Gynecologic resident
Other areas of specialty/work
Street address
The Great Women Hospital, North Nejatolahi St, Krimkhane Zand Aven, Valliasr Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8890 0002
Fax
+98 21 8891 5959
Email
minaakrami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)