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

NCT06350227 | Recruiting FDA Device

• 1 other identifier: WestChinaSU
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cyst Benign

Outcome Measures

Primary Outcomes (1)

• Antral Follicle Count (AFC)

  Antral follicle count (AFC) generally refers to the basic follicles in ovaries, which have not yet begun to develop. If the number of AFC is within the normal range (usually 5-10), it indicates that the ovarian reserve function is normal. If the number is low, it generally means that the ovarian reserve function is relatively low. If the number is high, it may be caused by polycystic ovary syndrome. Besides, AFC can be detected through ultrasound examination, and the number of AFC can directly reflect the ovarian reserve of each ovary.

  Preoperative quantity and postoperative quantity for 1, 3, and 6 months

Secondary Outcomes (1)

• Anti-Mullerian hormone (AMH)

  Preoperative level and postoperative level at 1, 3, and 6 months

Study Arms (3)

The absorbable hemostat

EXPERIMENTAL

Combination Product: the absorbable hemostat and suture

Electrocoagulation

ACTIVE COMPARATOR

Combination Product: electrocoagulation and suture

Suture alone

PLACEBO COMPARATOR

Other: suture

Interventions

the absorbable hemostat and suture COMBINATION_PRODUCT

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

The absorbable hemostat

electrocoagulation and suture COMBINATION_PRODUCT

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

Electrocoagulation

suture OTHER

The placebo comparator is to use suture alone for hemostasis.

Suture alone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

Sutures; Electrocoagulation

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Yanru Long

CONTACT

86-13550169017; 2801443341@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CN (1)