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Sponsors and Collaborators: |
Shandong Provincial Hospital Shandong University |
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Information provided by: | Shandong Provincial Hospital |
ClinicalTrials.gov Identifier: | NCT00713778 |
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 |
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Ovarian Cysts |
Procedure: Ovarian cystectomy |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc |
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 |
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1: Experimental
Laparoscopic ovarian cystectomy using bipolar
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Procedure: Ovarian cystectomy
Laparoscopic ovarian cystectomy using bipolar
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2: Experimental
Laparoscopic ovarian cystectomy using ultrasonic scalpel
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Procedure: Ovarian cystectomy
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
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3: Active Comparator
Laparotomic ovarian cystectomy using suture
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Procedure: Ovarian cystectomy
Laparotomic ovarian cystectomy using suture
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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
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
China, Shandong | |
Shandong Provincial Hospital | |
jinan, Shandong, China, 250021 |
Study Director: | changzhong li, M.D. | Shandong Provincial Hospital |
Responsible Party: | Shandong Provincial Hospital ( Xiayong Wang Ph.D ) |
Study ID Numbers: | SPH-CL-030408 |
Study First Received: | July 7, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00713778 |
Health Authority: | China: Ministry of Health |
Ovarian Cysts Electrocoagulation Ovarian Function Tests Laparoscopy |
Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Endocrinopathy |
Ovarian Diseases Cysts Ovarian Cysts |
Neoplasms Adnexal Diseases |