define and compare the average of Hb decrease and the duration of surgery and hospitalized days and to define the amount of deficit fluid, electrolyte imbalance and the size of myoma in hystroscopical myomectomy by injecting vasopressin and without injecting vasopressin
Design
This study is a one_side_blind randomized clinical trial. The way of sampling is simple. In this study the patients who are candidates for hystroscopical myomectomy are divided into 2 groups accidentally, there are 22 people in each group. One group will receive transcervical intralesion vasopressin and the second group won't receive any drug.
Settings and conduct
The first group will have a surgery called conventional hysteroscopical myomectomy, and the second group will have hysteroscopical myomectomy surgery with injecting vasopressin. In this study 20 unit vasopressin is diluted in 60 cc normal salin to have .1 unit in 1 cc. Then 3 cc is injected in 3 points by needle injection around the myoma, and after that the resection of the myoma will be begin. The blood sample is taken in order to check the amount of Hb decrease and electrolyte imbalance 4 hours after the surgery.
Participants/Inclusion and exclusion criteria
the women 18 to 62 years old and had given permission to be studied. In all the patients the existence of the submucosal myoma was approved by sonography or hysterescopy. the people who expired during the surgery are out of the study.
Intervention groups
The patients are divided accidentally into two groups,. The first group will have hysterescopic myomectomy with vasopressin, the placebo group without vasopressin.
Main outcome variables
Comparing the average of Hb decrease, duration of surgery, hospitalized days, average of deficite volume, electrolyte imbalances and the size of myoma.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120201008897N6
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Safoura Rouholamin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7001
Email address
s_rouholamin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the outcome of hystroscopic myomectomy with and without vasopressin injection in women with submucosal myoma
Public title
The effect of vasopressin on outcome of hystroscopic myomectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women in 18 years old until 62 years old who has submucosal myoma
in all of them the existence of submucosal myoma was approved
The women have the testimonial
Exclusion criteria:
those who have died during surgery
Age
From 18 years old to 62 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
people are accidentally divided in two groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study the patients, outcome assessor and data analyser don't know which participant has received vasopressin and which one has received the placebo.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Esfahan
Province
Isfehan
Postal code
1417614411
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.MUI.REC.1396.3.113
Health conditions studied
1
Description of health condition studied
Hysterescopic myomectomy
ICD-10 code
D25.0
ICD-10 code description
Submucous leiomyoma of uterus
Primary outcomes
1
Description
Hb decrease
Timepoint
the day after surgery
Method of measurement
kit lab
2
Description
hyponatremia
Timepoint
the day after surgery
Method of measurement
kit lab
3
Description
hypo kalemia
Timepoint
the day after surgery
Method of measurement
kit lab
4
Description
deficite volume
Timepoint
after the ending of surgery
Method of measurement
surgeon 's estimate
5
Description
the length of surgery
Timepoint
duration of surgery
Method of measurement
minutes
6
Description
hospitalised day
Timepoint
hospitalized duration
Method of measurement
counting day
7
Description
size of myoma
Timepoint
during surgery
Method of measurement
cheklist
Secondary outcomes
empty
Intervention groups
1
Description
hystroscopic myomectomy with vasopressin
Category
Treatment - Surgery
2
Description
hystroscopic myomectomy without vasopressin
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Safoura Rouholamin
Street address
Alzahra Hospital, Boulevard Shohadaye Sofe, Three Hakim Nezami
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Review the complications of hysterescopic myomectomy with and without vasopressin
When the data will become available and for how long
The time of accessibility is a month after publishing the information
To whom data/document is available
The information is available for everyone
Under which criteria data/document could be used
The information is available for everyone and everyone is allowed to do any kind of analyses on them
From where data/document is obtainable
address: University of medical siences, Hezar jarib strees, Darvazeh Shiraz, Isfahan
postal code:1417614411
phone:00983136202020
website://alzahra.mui.ac.ir
Dr Safoura Rouholamin
What processes are involved for a request to access data/document
The demandant should send her/his name, occupation, field of studyng and purpose in an email. The requested information will be sent in a week.