Yiwu Cold Knife Technique Versus Electrocision for Multiple Endometrial Polyps

NCT07737301 | Not Yet Recruiting

• 1 other identifier: KY-2026-034
• Study Type: interventional
• Target: 850
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Yiwu Cold Knife Technique for Multiple Endometrial Polyps

Keywords

Endometrial Polyps; Hysteroscopic polypectomy; Cold knife hysteroscopy; Electroresection hysteroscopy; Endometrial polyps recurrence; Abnormal uterine bleeding; Uterine benign lesions; Minimally invasive uterine surgery; Multi-center randomized controlled non-inferiority trial; 1-year postoperative follow-up

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate of Endometrial Polyps at 12 Months Postoperatively

  The proportion of patients with newly detected endometrial polyps confirmed by transvaginal ultrasound at 12 months after surgery.

  12 months after surgery

Study Arms (2)

Cold knife hysteroscopic polypectomy (Yiwu procedure)

EXPERIMENTAL

Participants receive mechanical removal of multiple endometrial polyps via cold scissors or morcellators without electric thermal energy. Standard perioperative management is provided.

Procedure: Cold knife hysteroscopic polypectomy (Yiwu procedure)

Electroresection hysteroscopic polypectomy

ACTIVE COMPARATOR

Participants undergo routine hysteroscopic electroresection with high-frequency current for polyp excision and hemostasis. Identical preoperative, anesthetic and postoperative care as the experimental arm.

Procedure: Electroresection hysteroscopic polypectomy

Interventions

Cold knife hysteroscopic polypectomy (Yiwu procedure) PROCEDURE

Endometrial polyps are removed by mechanical cutting using hysteroscopic micro-scissors or morcellators. No electrosurgical energy is used for resection or hemostasis; bleeding control relies only on mechanical compression of the wound base. No thermal injury to surrounding endometrium is permitted during the operation.

Cold knife hysteroscopic polypectomy (Yiwu procedure)

Electroresection hysteroscopic polypectomy PROCEDURE

Endometrial polyps are excised with standard hysteroscopic electrosurgical loops. High-frequency electric current is applied for tissue cutting and intraoperative hemostasis. Thermal ablation of normal endometrial tissue outside polyp lesions is prohibited per trial protocol.

Electroresection hysteroscopic polypectomy

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07