To evaluate postoperative adhesion after laparoscopic surgery for endometrioma ovarian suspension is evaluated.
Endometriosis is one of the leading cause of morbidity in women of reproductive age. Endometriosis is common in Iran, so a safe surgery has an important role in women health in Iran. Typical symptoms of endometriosis are dysmenorrehea, dysparunia, pelvic pain and infertility, that all of them have negative impact on quality of life of patients. Excisional surgery is one of the most effective treatment modalities for advance pelvic endometriosis. However laparoscopic surgery has fewer adhesion formation regarding laparatomy , many of patients after laparoscopy develop adhesion formation . Adhesion formation are occurred on ovaries , and posterior culdesac and results chronic pelvic pain, dysparunia, dysmenorrehea, bowel obstruction and infertility.
All patients with bilateral ovarian endometrioma who are candidate for laparoscopic surgery are included in the study. During surgery ovarian suspension is done for better exposure of pelvic floor and posterior cul de sac, after completing surgery suture are released . At present trial suture in one side is saved and as the placebo a superfacial suture in other site is applied but ovary is in normal position in this site and other ovary is suspended . After 7 day both suture are removed. At the same day and 2 months later transvaginal sonogram is done for evaluation of ovarian adhesion in both sides.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402122576N9
Registration date:2015-11-20, 1394/08/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-20, 1394/08/29
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-12-01, 1395/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of ovarian suspensions in preventing post-operative ovarian adhesion in women with severe pelvic endometriosis
Public title
Effectiveness of ovarian suspensions in preventing post-operative ovarian adhesion in women with severe pelvic endometriosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with endometriosis stage 3-4; Bilateral ovarian endometrioma
Exclusion criteria:
History of pelvic or abdominal tuberculosis; Patients without informed consent for participating in study
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethicas Committee of research deputy of Tehran University of Medical Sciences
Street address
5th floor, Central building of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.TUMS.REC.1394.1147
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Evaluation of ovarian adhesion
Timepoint
7th day
Method of measurement
Transvaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Ovary is suspended by suture at the time of surgery
Category
Treatment - Surgery
2
Description
Control : Contralateral ovary is left insitu but a suture is applied on surface as placebo
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirza Koch Khan(Mohebe Yas) Hoapital
Full name of responsible person
Fatemeh Davari Tanha
Street address
North Ostad Nejatollahi avenue, Karim Khan Zand Bridge ,Vila street
City
Tehran
2
Recruitment center
Name of recruitment center
Infertility & Recurrent abortion Center of Avecinna
Full name of responsible person
Atefe Gorgin
Street address
No 97, Yakhchal Avenue, Shariati Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Fifth floor- Central building of Tehran University of Medical Sciences-Ghods Ave- Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of 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
Fatemeh Davari Tanha
Position
Associate professor
Other areas of specialty/work
Street address
Mohebe Yas(Mirza Kochak Khan) hospital, North Ostad nejatollahi , Karim khan Zand Bridge, Villa street
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
fatedavtanha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate professor
Other areas of specialty/work
Street address
Mohebe Yas Hospital, North Ostadnejatollahi Avenue , Karim Khan Zand Bridge ,Villa street
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
fatedavtanha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Infertility fellowship
Other areas of specialty/work
Street address
Mirza Kochak Khan (Moheb Yas) hospital,North Ostad Nejatollahi avenue, Karim Khan Zand Bridge , Vila street
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)