The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 3, 2012
June 1, 2012
1.4 years
June 26, 2012
June 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Preoperative and postoperative changes in anti-mullerian hormone level
The primary outcome of our study is the impact on ovarian reserve determined by AMH after the application of the three laparoscopic techniques for the treatment of ovarian cyst.In all study patients, at preoperation and 1 week, 1 month, 3 month after operation, AMH is serially measured.
preoperative, postoperative at 1week, 1 and 3 months
Secondary Outcomes (1)
postoperative pain scores
Study Arms (3)
single-port access laparoscopic ovarian cyst enucleation
ACTIVE COMPARATORProcedure: 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.)
two-port laparoscopic access ovarian cyst enucleation
ACTIVE COMPARATORProcedure: 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.
four-port access laparoscopic ovarian cyst enucleation
ACTIVE COMPARATORProcedure: : Operative laparoscopic ovarian cyst enucleation was performed through insertion of a 12-mm subumbilical trocar and three 5-mm trocars in the lower abdomen.
Interventions
Eligibility Criteria
You may qualify if:
- Age: 21-45 years Ultrasound
- 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.
You may not qualify if:
- Previous ovarian surgery
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHA Universitylead
Study Sites (1)
Gangnam CHA medical center
Seoul, Gamnamgu, South Korea
Related Publications (1)
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.
PMID: 24630293DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 29, 2012
Study Start
October 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 3, 2012
Record last verified: 2012-06