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

W

West China Second University Hospital

Status

Enrolling

Conditions

Ovarian Cyst Benign

Treatments

Combination Product: the absorbable hemostat and suture
Other: suture
Combination Product: electrocoagulation and suture

Study type

Interventional

Funder types

Other

Identifiers

NCT06350227
WestChinaSU

Details and patient eligibility

About

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.

Enrollment

165 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

165 participants in 3 patient groups, including a placebo group

The absorbable hemostat
Experimental group
Treatment:
Combination Product: the absorbable hemostat and suture
Electrocoagulation
Active Comparator group
Treatment:
Combination Product: electrocoagulation and suture
Suture alone
Placebo Comparator group
Treatment:
Other: suture

Trial contacts and locations

1

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Central trial contact

Yanru Long

Data sourced from clinicaltrials.gov

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