The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
NCT ID: NCT01631253
Last Updated: 2012-07-03
Study Results
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Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2011-10-31
2013-03-31
Brief Summary
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Detailed Description
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However, some limits could be occurred, such as the occurrence of less freedom degrees between the instruments and limits surgical vision, thus limiting surgeon's movements. So, two-port laparoscopy combined access through umbilical and additional suprapubic incision have been used and reported. In case of single port access laparoscopic ovarian cyst enucleation, due to limits of surgeon's movements, cyst enucleation or bipolar electrocoagulation of the ovarian parenchyma adversely affected ovarian function.
Some studies reported that after laparoscopic cyst enucleation, there had been shown marked reduction of ovarian function compared with surgery by laparotomy. Therefore we attempt to investigate the impact of single port laparoscopy that have limits of surgical procedures on ovarian reserve after ovarian cyst enucleation.
To evaluate ovarian reserve change, we will use the anti-mullerian hormone. It is produced by granulosa cells of preantral and small antral follicles and has been recently acknowledged as the useful, reliable, and sensitive hormonal serum marker of the ovarian primordial follicle pool. In addition, the AMH level represents a stronger independent marker of ovarian reserve without significant fluctuation during the menstrual cycle, which progressively decreases with age.
Therefore, this prospective study is performed to compare the differences in ovarian reserve after single-port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Serum anti mullerian hormone is measured at preoperative and at postoperative 1week, 1 and 3 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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single-port access laparoscopic ovarian cyst enucleation
Procedure: Operative laparoscopic ovarian cyst enucleation was performed only through an umbilical single port. ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with three 5mm trocars inserted into three fingers was draped around the rim of the wound retractor.)
Laparoscopic ovarian cyst enucleation
two-port laparoscopic access ovarian cyst enucleation
Procedure: Operative access laparoscopic ovarian cyst enucleation was performed using an umbilical single port ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with two 5mm trocars inserted into two fingers was draped around the rim of the wound retractor.) and one 5-mm trocar in the lower abdomen.
Laparoscopic ovarian cyst enucleation
four-port access laparoscopic ovarian cyst enucleation
Procedure: : Operative laparoscopic ovarian cyst enucleation was performed through insertion of a 12-mm subumbilical trocar and three 5-mm trocars in the lower abdomen.
Laparoscopic ovarian cyst enucleation
Interventions
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Laparoscopic ovarian cyst enucleation
Eligibility Criteria
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Inclusion Criteria
* CT, MRI diagnosis as ovarian cyst , need to cyst enucleation
* Size of cyst : between 3cm and 10cm
* Regular menstrual cycles defined as cycle length between 25 and 35 days
* Agreement to be enrolled in the study.
Exclusion Criteria
* suspicious of malignancy
* Postmenopause
* Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months
* Known endocrine disorder
21 Years
45 Years
FEMALE
No
Sponsors
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CHA University
OTHER
Responsible Party
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Seok Ju Seong
Principal Investigator
Locations
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Gangnam CHA medical center
Seoul, Gamnamgu, South Korea
Countries
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Facility Contacts
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seok ju Seong
Role: primary
References
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Yoon BS, Kim YS, Seong SJ, Song T, Kim ML, Kim MK, Paek JY. Impact on ovarian reserve after laparoscopic ovarian cystectomy with reduced port number: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:34-8. doi: 10.1016/j.ejogrb.2014.02.025. Epub 2014 Feb 20.
Other Identifiers
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SPA001
Identifier Type: -
Identifier Source: org_study_id