The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

Ovarian Cyst Clinical Trial

Official title:

The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01631253
• Other study ID #: SPA001
• Status: Recruiting
• Phase: Phase 4
• First received: June 26, 2012
• Last updated: June 30, 2012
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2012
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

With the recent development of surgical instruments techniques, minimally invasive surgery is more feasible in various field of surgery. Laparoscopic surgery has potential benefit of decreased patient discomfort, short hospital stay, superior cosmetic results and decreased convalescence time. Recently, various efforts have been continued for minimally invasive surgery, one of the recently emerging concepts is single port surgery. Several studies have demonstrated that single-port laparoscopic surgery is feasible and safe in gynecology.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cysts
• Ovarian Cyst
• Ovarian Cysts

Intervention

Procedure:
• Laparoscopic ovarian cyst enucleation

Locations

Country	Name	City	State
Korea, Republic of	Gangnam CHA medical center	Seoul	Gamnamgu

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	postoperative pain scores			No