Comparative Study of the Effect of "Electrocautery" and "Suture" Homeostasis on Laparoscopic non-endometriotic benign Ovarian Cyst on Mean Anti mullerian Hormone Levels
1. Determination and Comparison of the Effect of "Electrocautery" and "Suture" Hemostasis Methods on Laparoscopic non-endometriotic Benign Ovarian Cysts on Mean Anti Mullerian Hormone Levels
2. Determination and Comparison of Mean Anti Mullerian Hormone Levels in Two Groups of Patients (Hemostasis with Electrocautery and Suture) before and Three Months after Laparoscopic Cystectomy
Design
A clinical trial with randomized parallel groups; total sample size 50 patients
Settings and conduct
Individuals of Reproductive Age who are Candidates for Excision of Non-endometriotic Ovarian Cysts with Laparoscopic Benign Features are Identified. Patients'AMH and Hemoglobin Levels in these Patients are Measured Preoperatively in a Single Center at Al-Zahra Hospital Laboratory.Intraoperative Bleeding will be Control Randomly using a Bi-polar or Suture . Patients will also be Monitored for Hemoglobin 24 hours after Surgery and will be Measured and AMH was Recorded again three Months after Surgery.
Participants/Inclusion and exclusion criteria
Informed Consent, Ages 15 to 42,Having Criteria for Ovarian Cyst Removal;
Malignant Ovarian Cysts, Ovarian Endometriotic Cysts, History of Malignant Disease and Receiving Chemotherapy, History of Ovarian Surgery, Patients with a History of Illness and Coagulation Problems
Intervention groups
Randomly Controlled Bleeding by Cutter or Suture And Comparison of the Effect of Two Methods on Mean Level of Anti-Mullerian Hormone
Main outcome variables
Evaluation of the Better Effectiveness of "Electrocautery" and "Suture" Hemostasis on Mean Anti Mullerian Hormone Levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200113046116N1
Registration date:2020-02-08, 1398/11/19
Registration timing:registered_while_recruiting
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Mahsa Tavoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3273 0922
Email address
mehdikhosravi29@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Effect of "Electrocautery" and "Suture" Homeostasis on Laparoscopic non-endometriotic benign Ovarian Cyst on Mean Anti mullerian Hormone Levels
Public title
Comparison of "Electrocautery" and "Suture" Mean Anti mullerian Hormone Levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals who entered the study with informed consent
People aged 15 to 42 years
The patient has criteria for removal of the ovarian cyst
Exclusion criteria:
Ovarian malignant cysts
Ovarian endometriotic cysts
A history of malignant diseases and receiving chemotherapy
People with a history of ovarian surgery
Patients with a history of illness and coagulation problems
Age
From 15 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib
Intervention group: homeostasis with suture. After laparoscopic benign ovarian cyst removal, patients underwent a suture for homeostasis and preoperative and 3 months postoperative antimalarial hormone levels were measured by Kobas mMachine in Al-Zahra hospital laboratory.
Category
Treatment - Devices
2
Description
Intervention group: homeostasis with electrocautery. After laparoscopic benign ovarian cyst removal, patients underwent cutter for homeostasis and preoperative and 3 months postoperative antimalarial hormone levels were measured by Kobas machine in Al-Zahra hospital laboratory.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Mahsa Tavoli
Street address
Sofeh Ave, Al Zahra hospital
City
Isfahan
Province
Isfehan
Postal code
8154735811
Phone
+98 31 3273 0922
Email
mehdikhosravi29@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghaegh Haghjoo
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Tavoli
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al Zahra hospital, Sofeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8154735811
Phone
+98 31 3273 0922
Email
mehdikhosravi29@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Tavoli
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al Zahra hospital, Sofeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8154735811
Phone
+98 31 3273 0922
Email
mehdikhosravi29@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Tavoli
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al Zahra hospital, Sofeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8154735811
Phone
+98 31 3273 0922
Email
mehdikhosravi29@yahoo.com
Sharing plan
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All Data Can be Shared، After Patients are Unrecognizable
When the data will become available and for how long
Start of Access Period from 1399
To whom data/document is available
All Interested People
Under which criteria data/document could be used
Commitment to Mention the Main Source
From where data/document is obtainable
Mahsa Tavoli, mehdikhosravi29@yahoo.com
What processes are involved for a request to access data/document