The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

This study has been completed.
Sponsor:
Collaborator:
Shandong University
Information provided by:
Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT00713778
First received: July 7, 2008
Last updated: August 15, 2008
Last verified: July 2008
  Purpose

The purpose of this study is to investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.


Condition Intervention Phase
Ovarian Cysts
Procedure: Ovarian cystectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

Resource links provided by NLM:


Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:
  • Serum FSH and E2 assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: November 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Laparoscopic ovarian cystectomy using bipolar
Procedure: Ovarian cystectomy
Laparoscopic ovarian cystectomy using bipolar
Other Name: laparoscopic ovarian cystectomy using bipolar
Experimental: 2
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Procedure: Ovarian cystectomy
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
Other Name: laparoscopic ovarian cystectomy using ultrasonic scalpel
Active Comparator: 3
Laparotomic ovarian cystectomy using suture
Procedure: Ovarian cystectomy
Laparotomic ovarian cystectomy using suture
Other Name: Laparotomic ovarian cystectomy using suture

Detailed Description:

Laparoscopic cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. In the present study, with the combined use of serum hormonal evaluation and ultrasound examination, we planned to prospectively investigate the ovarian reserve after the excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a 12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation or suture during ovarian cystectomy

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 18-40 years
  • Uni/bilateral ovarian cyst(s) without clinical and sonographic suspicion of ovarian cancer
  • Regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery
  • Agreement to be enrolled in the study

Exclusion criteria:

  • Prior ovarian surgery
  • Surgical necessity to perform adnexectomy
  • Known endocrine disease
  • Post operative pathologic diagnosis was not benign ovarian cyst
  • Oral contraceptive use before surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00713778

Locations
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
Shandong University
Investigators
Study Director: changzhong li, M.D. Shandong Provincial Hospital
  More Information

Publications:
Responsible Party: Xiayong Wang Ph.D, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT00713778     History of Changes
Other Study ID Numbers: SPH-CL-030408
Study First Received: July 7, 2008
Last Updated: August 15, 2008
Health Authority: China: Ministry of Health

Keywords provided by Shandong Provincial Hospital:
Ovarian Cysts
Electrocoagulation
Ovarian Function Tests
Laparoscopy

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 October 19, 2014