Protocol summary

Summary
This study is an interventional clinical trial, in order to determine and implement the best techniques for hemostasis in patients with endometrioma cystectomy that surgery necessity is diagnosed for them. Inclusion criteria for our study are patients aged 18-42 years, regular menstrual cycles with ovarian endometrioma, complaining of dysmenorrhea, infertility or pelvic mass for whom surgery is considered necessary. Exclusion criteria is also a history of ovarian surgery, pelvic inflammatory disease, previous chemotherapy or endocrine diseases (such as diabetes or hyper prolactinoma). Anti-Mullerian hormone levels, estradiol and FSH on the third day of the menstrual cycle before surgery are measured. The laparoscopic cystectomy performed on patients using atromatic graspers then hemostasis with bipolar electrocoagulation or suturing technique, randomly was done by a surgeon. The number of calculated samples in each group is 44. Again 3 months after surgery, the laboratory tests on the third day of the menstrual cycle will be measured. The post operative results of anti-Mullerian hormone, estradiol, and FSH with preoperative values ​​in both groups (surgical hemostasis with bipolar and suturing) and also between the two groups will be compared. Then, these comparisons should be interpreted.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403088897N2
Registration date: 2014-04-13, 1393/01/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-13, 1393/01/24
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
Tehran University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of ovarian reserve after laparascopic cystectomy of endometrioma using bipolar electrocoagulation versus intracorporeal suture: Clinical trial study
Public title
Evaluation of ovarian reserve after laparascopic cystectomy of endometrioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 18-42 years old who candidate for surgury because of dysmenorrhea,suspesious endometrioma or infertility Exclusion criteria: Previous history of ovarian surgury or pelvic surgury; Previous endocrinology disease (DM, hyperprolactinoma and thyroid disease); pelvic inflammatory disease (PID); Previous history of chemotherapy
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Pourcina St, Keshavars Bul, Meical faculty
City
Tehran
Postal code
1417614411
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
24207-30-03-92

Health conditions studied

1

Description of health condition studied
Endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary

Primary outcomes

1

Description
َAnti mullerian hormone
Timepoint
One cycle before and 3 cycle after surgury
Method of measurement
ng/ml

2

Description
FSH
Timepoint
One cycle before and 3 cycle after surgury
Method of measurement
U/L

3

Description
Estradiol
Timepoint
One cycle before and 3 cycle after surgury
Method of measurement
U/L

Secondary outcomes

1

Description
HB
Timepoint
Before and 24 hours after surgury
Method of measurement
gr/dl

Intervention groups

1

Description
Cystectomy of endometrioma and controle of hemostasis with bipolar electrocoagulation
Category
Treatment - Surgery

2

Description
Cystectomy of endometrioma and controle of hemostasis with suturing
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital, Laparascopic Ward
Full name of responsible person
Safoura Rouholamin
Street address
Arash Hospital, Rashid St, Tehranpar
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Khalilpour
Street address
Poorcina street, Keshavars Bul, Medical Faculty
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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Asgari
Position
Associated professor
Other areas of specialty/work
Street address
Arash hospital, Rashid St, Tehranpars
City
Tehran
Postal code
Phone
+98 21 7773 3934
Fax
Email
Dr.zahra.asgari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Assistant professor of Isfahan medical university
Full name of responsible person
Safoura Rouholamin
Position
Obstetrics and Gynecologist, Laparascopic flowship
Other areas of specialty/work
Street address
No.109, West160 alley, Rashid street, Tehranpars
City
Tehran
Postal code
Phone
+98 21 7773 6647
Fax
Email
s_rouholamin@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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