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

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ClinicalTrials.gov Identifier: NCT00713778
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : August 18, 2008
Sponsor:
Collaborator:
Shandong University
Information provided by:
Shandong Provincial Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cysts Procedure: Ovarian cystectomy Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc
Study Start Date : November 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Serum FSH and E2 assays [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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): 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

Publications:
Responsible Party: Xiayong Wang Ph.D, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT00713778     History of Changes
Other Study ID Numbers: SPH-CL-030408
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: July 2008

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

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