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NCT07737301
Yiwu Cold Knife Technique Versus Electrocision for Multiple Endometrial Polyps
Conditions: Yiwu Cold Knife Technique for Multiple Endometrial Polyps
Sex: Female
Ages: 20 Years – 48 Years
Healthy volunteers: No
Phase: NA
Enrollment: 850
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Summary
\# Clinical Trial Summary Template (Based on your endometrial polyp study)
The goal of this clinical trial is to learn if cold knife hysteroscopic polypectomy (Yiwu procedure) works to treat multiple endometrial polyps in women. It will also learn about the surgical safety of cold knife hysteroscopic polypectomy (Yiwu procedure). The main questions it aims to answer are:
Does cold knife hysteroscopic polypectomy (Yiwu procedure) achieve a 1-year postoperative recurrence rate that is non-inferior to electroresection hysteroscopic polypectomy? What intraoperative and postoperative adverse events and complications do participants experience after receiving either surgical treatment? Researchers will compare cold knife hysteroscopic polypectomy (Yiwu procedure) to standard electroresection hysteroscopic polypectomy to verify whether the cold knife technique can reduce endometrial polyp recurrence without increasing surgical risks.
Participants will:
Receive either cold knife hysteroscopic polypectomy or conventional electroresection hysteroscopic polypectomy as standardized surgery Attend clinic follow-up visits at 3, 6 and 12 months after surgery for physical examinations and transvaginal ultrasound scans Complete clinical assessment records including menstrual status, abnormal uterine bleeding symptoms, pain conditions and patient satisfaction scores throughout the 1-year follow-up period
Eligibility Criteria
Inclusion Criteria:
Aged 20 to 48 years. Regular menstrual cycles (22-35 days); no need for postoperative artificial cycle therapy. Patients requiring long-term medication such as those with PCOS are excluded.
Voluntarily decline Mirena insertion, oral contraceptives or other progestogen therapy after surgery.
Diagnosed with multiple endometrial polyps confirmed by at least one transvaginal ultrasound examination.
Scheduled to undergo hysteroscopic treatment. Generally good health status apart from endometrial polyps. Normal cervical screening results, or results requiring no therapeutic intervention after assessment.
No pregnancy plan within 1 year after hysteroscopic surgery. Able to provide written informed consent.
Exclusion Criteria:
Postmenopausal women. Irregular menstrual cycles requiring postoperative hormonal intervention (e.g., polycystic ovary syndrome, PCOS).
Pregnant or breastfeeding women (interval between delivery, miscarriage or lactation and treatment initiation less than 3 months).
History of endometrial ablation, pelvic radiation therapy, etc. Current use of tamoxifen or similar agents. Confirmed malignant genital tract tumor or breast cancer. Poor follow-up compliance and inability to complete 1-year follow-up. Other conditions deemed inappropriate for enrollment by investigators. Concurrent participation in another clinical drug trial. Inability to comply with the study protocol for any reason. Concurrent uterine malformation requiring synchronous surgery, moderate or severe intrauterine adhesions, embedded intrauterine device, submucous myoma greater than 1 cm, and other similar conditions.
Combined severe internal diseases or surgical contraindications.
Source: ClinicalTrials.gov (NCT07737301). StuddyBuddy aggregates publicly available trial information.