Comparing hemostasis methods during laparoscopic surgery for benign ovarian cysts

Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

This study is testing different ways to stop bleeding during laparoscopic surgery for benign ovarian cysts to see which method is best for preserving women's ovarian health and fertility.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: West China Second University Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06350227 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of various hemostasis techniques used during laparoscopic ovarian cystectomy on ovarian function and fertility in women diagnosed with benign ovarian cysts. Participants will be randomly assigned to one of three hemostatic methods: absorbable hemostat and suture, electrocoagulation and suture, or suture alone. The study will include women aged 18 to 40 who have been diagnosed with unilateral or bilateral benign ovarian cysts, confirmed by ultrasound and postoperative examination. The goal is to determine which method has the least impact on ovarian health and fertility outcomes.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 40 with benign ovarian cysts requiring laparoscopic surgery.

Not a fit: Patients with conditions such as polycystic ovary syndrome or those who are pregnant or lactating will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical techniques that preserve ovarian function and enhance fertility in women undergoing laparoscopic cystectomy.

How similar studies have performed: While there have been studies on hemostasis methods in surgery, this specific comparison in the context of ovarian cystectomy is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Women diagnosed with benign ovarian cysts requiring surgical management.
2. Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
3. Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
4. Women aged between 18 and 40 years old.
5. It was diagnosed by ultrasound as unilateral or bilateral benign ovarian cysts with a maximum diameter of 4-8cm. The nature of the cysts is ultimately confirmed by postoperative pathological examination.
6. Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.
7. Patients with no history of endocrine disorders such as hyperprolactinemia, hypothyroidism, or hyperthyroidism, and no history of endocrine therapy within 6 months before laparoscopic ovarian cystectomy.

Exclusion Criteria:

1. Polycystic ovary syndrome.
2. Pregnancy or lactation period.
3. Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
4. Women who have undergone two or more pelvic or abdominal surgeries.
5. Evidence of premature ovarian failure or premature menopause, such as AMH\<1ng/ml.
6. Conversion to open surgery.
7. Women who refuse to sign informed consent or are unable to attend follow-up regularly.
8. Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.

Where this trial is running

Chengdu, Sichuan

• West China Second University Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yanru Long

Conditions Ovarian Cyst Benign