RecruitingNot ApplicableNCT06350227
Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
Sponsor
West China Second University Hospital
Enrollment
165 participants
Start Date
Apr 10, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years
Inclusion Criteria7
- Women diagnosed with benign ovarian cysts requiring surgical management.
- Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
- Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
- Women aged between 18 and 40 years old.
- 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.
- Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.
- 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 Criteria8
- Polycystic ovary syndrome.
- Pregnancy or lactation period.
- Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
- Women who have undergone two or more pelvic or abdominal surgeries.
- Evidence of premature ovarian failure or premature menopause, such as AMH<1ng/ml.
- Conversion to open surgery.
- Women who refuse to sign informed consent or are unable to attend follow-up regularly.
- Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.
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Interventions
COMBINATION_PRODUCTthe absorbable hemostat and suture
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
COMBINATION_PRODUCTelectrocoagulation and suture
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.
OTHERsuture
The placebo comparator is to use suture alone for hemostasis.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06350227