Yiwu Cold Knife Technique Versus Electrocision for Multiple Endometrial Polyps

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-48
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

\# 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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cold knife hysteroscopic polypectomy (Yiwu procedure)

    Procedure/Surgery

    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.

  • Electroresection hysteroscopic polypectomy

    Procedure/Surgery

    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.

Treatment groups

850 Participants
are divided into 2 treatment groups
Group A: Cold knife hysteroscopic polypectomy (Yiwu procedure)Experimental treatment 1 intervention
Group B: Electroresection hysteroscopic polypectomyActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: