Comparison of the morbidity after laparoscopic surgery of ovarian endometrioma in patients with ovary suturing and control group: a randomization clinical trial
The aim of this study was to compare morbidity and mortality is suturing ovary compared with non-use of suture. This study will be conducted as a clinical trial multi centric. Inclusion criteria included women of reproductive age undergoing laparoscopic ovarian cystectomy, and exclusion criteria included patients with diabetes, immune deficiency, coagulation disorders and pathology report is suggestive of malignant ovarian cyst wall. The study population included women undergoing laparoscopic cholecystectomy larger than five centimeters ovarian referred to Hazrat-e-Rasoul and Pars Hospital barking, and sample size in this study is 82 Patients. After confirming the inclusion criteria and obtain the written consent of the individual, Use the table of random numbers into random groups have suture and non-suture. Ovarian cystectomy, laparoscopic surgery were randomly and ovaries surgically sutured with thread measurable in this study include measuring the amount of hemoglobin drop. fever ovarian reserve is allocated. Surgery by doctors at the hospital will be fixed. Measurement of anti-Mullerian hormone levels hemoglobin levels six hours after surgery blood in the third period and also to investigate the occurrence of fever after surgery to check for sublingual temperature every eight hours after the surgery is done if the readmission during the first six weeks after surgery control the patient's fever and hemoglobin concentration, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090923949N1
Registration date:2016-02-01, 1394/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Mansoureh Vahdat
Name of organization / entity
Iran University of medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
vahdat.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the morbidity after laparoscopic surgery of ovarian endometrioma in patients with ovary suturing and control group: a randomization clinical trial
Public title
Comparison of the morbidity after laparoscopic surgery of ovarian endometrioma in patients with ovary suturing and control group ( without ovary suturing).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women in reproductive age candidate for laparoscopic cystectomy for endometrioma
Exclusion criteria: Diabetes, immune deficiency, coagulopaty, malignancy in pathological exam
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
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 Iran University of Medical Science
Street address
Iran . Tehran . Hemat Highway . Milad Tower
City
Tehran
Postal code
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.IUMS.REC.1394.25324
Health conditions studied
1
Description of health condition studied
Ovarian cysts
ICD-10 code
N83.2
ICD-10 code description
Other and unspecified ovarian cysts
Primary outcomes
1
Description
Hemoglobin rate
Timepoint
One day before surgery and 6 hours after surgery.
Method of measurement
Bleeding sample
Secondary outcomes
1
Description
Hospital admission days
Timepoint
The 6 week after surgery.
Method of measurement
Day
2
Description
Fever
Timepoint
The 6 week after surgery.
Method of measurement
Thermometer
3
Description
Anti Mullerian hormone
Timepoint
The before surgery and third period after surgery.
Method of measurement
Bleeding sample
Intervention groups
1
Description
The intervention is suturing the ovary tissue by inverting the ovary wedgs using Vicryl 2-0
Category
Treatment - Surgery
2
Description
In control group not suturing the ovary tissue
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul e akram hospital
Full name of responsible person
Dr. Mansoureh vahdat
Street address
Niayesh Av. Sattar khan St. Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Pars general hospital
Full name of responsible person
Abolfazal Mehdizadeh kashi
Street address
No11, saeedi Alley, fereshteh St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Javad Musavi
Street address
Research Deputy office of Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Science
Full name of responsible person
Dr. Mansoureh Vahdat
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan St. Tehran
City
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
mansoureh_vahdat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Mansoureh Vahdat
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan St. Tehran, Iran.
City
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
mansoureh_vahdat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Mansoureh Vahdat
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan St, Tehran, Iran.
City
Tehran
Postal code
1449613131
Phone
+98 21 6655 5447
Fax
Email
mansoureh_vahdat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)