The comparison of two methods of closing the uterine vessels and the use of tourniquets in open myomectomy among patients admitted to Imam Sajjad Hospital in Yasouj.
Design
Clinical trial with 2 intervention groups with parallel groups, without blinding, without randomization, on 60 patients.
Settings and conduct
From the patients referred to Imam Sajjad hospital clinic for surgery appointment, a number of samples are selected and after hospitalization, the types of surgery and their consequences are explained. Then, in the operating room, one of the two surgical methods is performed on them and the amount of bleeding is checked. Patients are followed up for 2 week in terms of complications.
Participants/Inclusion and exclusion criteria
No history of underlying disease, coagulation problem, malignancy, previous myomectomy surgery, drug use to reduce the volume of myoma, and patient's consent and cooperation to provide information.
Intervention groups
In the ligation group, the uterine vessels will be closed bilaterally, and in the tourniquet group, the vessels will be closed with a penrose drain around the lower uterine segment.
Main outcome variables
Measuring the amount of bleeding after 2 surgical methods and comparing them
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221208056750N1
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Parvin Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 341 2031
Email address
pari.ghaffari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of closing uterine vessels and using tourniquet in open myomectomy among hospitalized patients
Public title
Comparison of two methods of uterine artery ligation and the use of tourniquets in open myomectomy among patients admitted to Imam Sajjad Hospital in Yasuj, Iran
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of underlying disease
Absence of coagulation problem
No history of malignancy
No history of previous myomectomy surgery
No history of taking medication to reduce myoma volume
Patient consent and cooperation to provide information
Exclusion criteria:
Lack of patient consent to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
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
Deputy of Research and technology of Yasuj University of Medical Sciences
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari boulevard, MHHQ+JHX
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.YUMS.REC.1400.125
Health conditions studied
1
Description of health condition studied
Patients with myoma in the uterus
ICD-10 code
P90-P96 Ot
ICD-10 code description
Certain conditions originating in the perinatal period
Primary outcomes
1
Description
The amount of Bleeding will be estimated according to the measurement of the weight of consumed gases, the amount of blood collected in the suction container and hemoglobin measurement, and this amount will be compared in two surgical methods.
Timepoint
Weighing the gases used during surgery and measuring the amount of blood collected in the suction container at the end - hemoglobin measurement 6 hours after the surgery
Method of measurement
Calculating the weight of completely wet gauze after surgery (about 46 grams) compared to the weight of a sterile gauze before surgery (about 6 grams) - Measuring the amount of blood collected in the suction container based on the amount of filled volume - Measuring hemoglobin 6 hours After surgery by venous blood test taken from the patient
2
Description
Investigation of possible complications and symptoms of the patient
Timepoint
Up to 2 weeks after discharge
Method of measurement
In this period, the possible symptoms and complications during the visits of the patients or the phone calls made by the patients to the given contact number are entered in the relevant checklist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the ligation group, uterine vessels are closed bilaterally by absorbable thread near the uterus without harming the uterus.
Category
Treatment - Surgery
2
Description
Intervention group: In the tourniquet group, first a penrose drain (0.75 inch) is placed around the lower segment of the uterus, a space is created in the broad ligament at the level of the connection between the cervix and the uterus, and the penrose drain is removed from it and tied under tension with a clamp. We hold it so that the uterine and ovarian vessels are completely closed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Sajad hospital
Full name of responsible person
Parvin Ghaffari
Street address
Kohgiluyeh and Boyer-Ahmad Province,Yasuj , next to Azadi Hotel
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 0163
Email
emamsajad@gmail.com
Web page address
Http://emamsajad.yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyyed Amin Hosseini
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari boulevard, MHHQ+JHX
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6079
Email
en@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghaffari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari boulevard, MHHQ+JHX
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
pari.ghaffari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghaffari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari boulevard, MHHQ+JHX
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
pari.ghaffari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shiva Torki Baghbadrani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari boulevard, MHHQ+JHX
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
dr.sheida.torki@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available