Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
NCT ID: NCT06350227
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2024-04-10
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The absorbable hemostat
the absorbable hemostat and suture
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
Electrocoagulation
electrocoagulation and suture
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.
Suture alone
suture
The placebo comparator is to use suture alone for hemostasis.
Interventions
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the absorbable hemostat and suture
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
electrocoagulation and suture
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.
suture
The placebo comparator is to use suture alone for hemostasis.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
40 Years
FEMALE
No
Sponsors
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West China Second University Hospital
OTHER
Responsible Party
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Yanru Long
Resident physician
Locations
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West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WestChinaSU
Identifier Type: -
Identifier Source: org_study_id
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