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

Shandong First Medical University

Status and phase: Completed; Phase 4

Conditions: Ovarian Cysts

Treatments: Procedure: Ovarian cystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00713778

SPH-CL-030408

Details and patient eligibility

About

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.

Full 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

Enrollment: 192 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

1

Experimental group

Description:

Laparoscopic ovarian cystectomy using bipolar

Treatment:

Procedure: Ovarian cystectomy

Procedure: Ovarian cystectomy

Procedure: Ovarian cystectomy

2

Experimental group

Description:

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Treatment:

Procedure: Ovarian cystectomy

Procedure: Ovarian cystectomy

Procedure: Ovarian cystectomy

3

Active Comparator group

Description:

Laparotomic ovarian cystectomy using suture

Treatment:

Procedure: Ovarian cystectomy

Procedure: Ovarian cystectomy

Procedure: Ovarian cystectomy