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

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ClinicalTrials.gov Identifier: NCT01631253

Recruitment Status : Unknown

Verified June 2012 by Seok Ju Seong, CHA University.
Recruitment status was: Recruiting

First Posted : June 29, 2012

Last Update Posted : July 3, 2012

Sponsor:

Information provided by (Responsible Party):

Seok Ju Seong, CHA University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cyst	Procedure: Laparoscopic ovarian cyst enucleation	Phase 4

Detailed 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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
Study Start Date :	October 2011
Estimated Primary Completion Date :	March 2013
Estimated Study Completion Date :	March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.)	Procedure: Laparoscopic ovarian cyst enucleation
Active Comparator: 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.	Procedure: Laparoscopic ovarian cyst enucleation
Active Comparator: 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.	Procedure: Laparoscopic ovarian cyst enucleation

Outcome Measures

Primary Outcome Measures :

Preoperative and postoperative changes in anti-mullerian hormone level [ Time Frame: preoperative, postoperative at 1week, 1 and 3 months ]
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.

Secondary Outcome Measures :

postoperative pain scores

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631253

Locations


Korea, Republic of
Gangnam CHA medical center	Recruiting
Seoul, Gamnamgu, Korea, Republic of
Contact: seok ju Seong sjseongcheil@yahoo.co.kr

Sponsors and Collaborators

CHA University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Seok Ju Seong, Principal Investigator, CHA University
ClinicalTrials.gov Identifier:	NCT01631253 History of Changes
Other Study ID Numbers:	SPA001
First Posted:	June 29, 2012 Key Record Dates
Last Update Posted:	July 3, 2012
Last Verified:	June 2012

Additional relevant MeSH terms:


Cysts Ovarian Cysts Neoplasms Pathological Conditions, Anatomical Ovarian Diseases	Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases

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