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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cyst Benign

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The absorbable hemostat

Group Type EXPERIMENTAL

the absorbable hemostat and suture

Intervention Type COMBINATION_PRODUCT

The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.

Electrocoagulation

Group Type ACTIVE_COMPARATOR

electrocoagulation and suture

Intervention Type COMBINATION_PRODUCT

The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.

Suture alone

Group Type PLACEBO_COMPARATOR

suture

Intervention Type OTHER

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.

Intervention Type COMBINATION_PRODUCT

electrocoagulation and suture

The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.

Intervention Type COMBINATION_PRODUCT

suture

The placebo comparator is to use suture alone for hemostasis.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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West China Second University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yanru Long

Resident physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanru Long

Role: CONTACT

86-13550169017

Facility Contacts

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Yanru Long

Role: primary

86-13550169017

Other Identifiers

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WestChinaSU

Identifier Type: -

Identifier Source: org_study_id

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