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Trial Title:
Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
NCT ID:
NCT06350227
Condition:
Ovarian Cyst Benign
Conditions: Official terms:
Cysts
Ovarian Cysts
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Combination Product
Intervention name:
the absorbable hemostat and suture
Description:
The hemostasis method of the experimental group is to use both the absorbable hemostat
and suture.
Arm group label:
The absorbable hemostat
Intervention type:
Combination Product
Intervention name:
electrocoagulation and suture
Description:
The active comparator group is to use electrocoagulation and suture simultaneously to
stop bleeding.
Arm group label:
Electrocoagulation
Intervention type:
Other
Intervention name:
suture
Description:
The placebo comparator is to use suture alone for hemostasis.
Arm group label:
Suture alone
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Second University Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanru Long
Phone:
86-13550169017
Email:
2801443341@qq.com
Start date:
April 10, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
West China Second University Hospital
Agency class:
Other
Source:
West China Second University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06350227
