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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by CHA University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seok Ju Seong, CHA University
ClinicalTrials.gov Identifier:
NCT01631253
First received: June 26, 2012
Last updated: June 30, 2012
Last verified: June 2012
History of Changes
  Purpose
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 Intervention Phase
Ovarian Cyst
 Procedure: Laparoscopic ovarian cyst enucleation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Ovarian Cysts
U.S. FDA Resources

Further study details as provided by CHA University:

Primary Outcome Measures:
  • Preoperative and postoperative changes in anti-mullerian hormone level [ Time Frame: preoperative, postoperative at 1week, 1 and 3 months ] [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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):

Responsible Party: Seok Ju Seong, Principal Investigator, CHA University
ClinicalTrials.gov Identifier: NCT01631253     History of Changes
Other Study ID Numbers: SPA001 
Study First Received: June 26, 2012
Last Updated: June 30, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cysts
Ovarian Cysts
Neoplasms
Pathological Conditions, Anatomical
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 28, 2016