A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve

Shandong First Medical University

Status and phase: Completed; Phase 4

Conditions: Ovarian Cyst

Treatments: Procedure: Laparoscopic ovarian cystectomy using bipolar; Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel; Procedure: Laparoscopic ovarian cystectomy using suture

Study type: Interventional

Funder types: Other

Identifiers

NCT00746278

SPH-CL-080512

Details and patient eligibility

About

Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned.

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

Full description

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-40 years
• ultrasound diagnosis as unilateral ovarian cyst and the average size between 5cm and 10cm
• no 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
• sonographic normal contralateral ovary
• agreement to be enrolled in the study.

Exclusion criteria

• prior ovarian surgery or known endocrine disease
• surgical necessity to perform adnexectomy
• intraoperative diagnosis of an abnormal contralateral ovary
• post operative pathologic diagnosis was not benign ovarian cyst
• oral contraceptive use before surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

1

Experimental group

Description:

Laparoscopic ovarian cystectomy using bipolar

Treatment:

Procedure: Laparoscopic ovarian cystectomy using bipolar

2

Experimental group

Description:

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

Treatment:

Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel

3

Active Comparator group

Description:

Laparoscopic ovarian cystectomy using suture

Treatment:

Procedure: Laparoscopic ovarian cystectomy using suture