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

May 8, 2024 updated by: Yanru Long, West China Second University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Second University Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The absorbable hemostat
Combination product: the absorbable hemostat and suture
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
Active Comparator: Electrocoagulation
Combination product: electrocoagulation and suture
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.
Placebo Comparator: Suture alone
Other: suture
The placebo comparator is to use suture alone for hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antral Follicle Count (AFC)
Time Frame: Preoperative quantity and postoperative quantity for 1, 3, and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Mullerian hormone (AMH)
Time Frame: Preoperative level and postoperative level at 1, 3, and 6 months
Anti-Mullerian hormone (AMH), which can be detected through blood tests, is considered a reliable marker produced by ovarian granulosa cells. The level of AMH indirectly reflects the number of ovarian follicular pools and the joint reserve of both ovaries. In addition, the level of AMH fluctuates less throughout the menstrual cycle. Besides, AMH is almost unrelated to the menstrual cycle and is not affected by gonadotropin-releasing hormone (GnRH) agonists or oral contraceptives.
Preoperative level and postoperative level at 1, 3, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Second University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaSU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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