Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments

NCT06150521 | Active Not Recruiting

• 1 other identifier: K2023084
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine fibroid are the most common benign tumor in the female reproductive system. Although many patients with uterine fibroid do not need to be treated because they are asymptomatic, some patients can experience compression, menorrhagia, pain, irregular bleeding or infertility. The symptoms caused by uterine fibroid are related to its location and size. Submucous fibroids constitute 5-10% of all uterine fibroids.The submucous hysteromyoma is the most likely to cause symptoms, often leads to menorrhagia, irregular bleeding or infertility. Hysteroscopic myomectomy is a commonly used minimally invasive procedure. The submucous myoma can be resected out by endoscopic resectoscope with electricloop (unipolar and bipolar) . It can preserve the uterus and fertility, also effectively alleviate symptoms. However, some specific complications have also followed，such as： hemorrhage，uterine perforation， pneumonedema，infections，adhesions，etc. Uterine perforation occurs when the electrode is working, there is a high risk of injury to adjacent anatomical structures. And even without perforation, sometimes thermal injury to adjacent organs may still be discovered in a few days after surgery.In addition，Many scholars have found that hysteroscopic electromyectomy has a higher risk of intrauterine adhesion than other intrauterine operations. In order to reduce the damage caused by energy source, especially the adverse effects of thermal damage on the endometrium, the new methods of hysteroscopic myomectomy currently include: the hysteroscopic tissue removal (HTR) system, the cold loop myomectomy， the Hysteroscopy Endo Operative system (HEOS)，etc. Existing studies show that，These manipulation techniques did not cause the myometrium damage by radiofrequency energy source, greatly reducing the risk of postoperative intrauterine adhesions. The cold knife hysteroscopic myomectomy in this study is a series of procedures using cold instruments（mechanically, with scissor, grasping or morcellation） to remove uterine submucosal fibroids. The purpose of this surgical technique is to make the operation safe and effective, with greater emphasis on the anatomical and physiological integrity of the myometrial and endometrial layers. This study aims to evaluate the safety and efficacy of cold knife hysteroscopic myomectomy.

Conditions

Hysteroscopic Myomectomy

Keywords

Hysteroscopy; Cold knife; Myomectomy; Submucous myoma

Outcome Measures

Primary Outcomes (5)

• Success rate

  Total removal of intrauterine pathology with cold knife hysteroscopic myomectomy was defined as a successful operation. During the operation, whether the fibroids were successfully removed by B-ultrasound examination and naked eye

  On the 1 day of surgery

• failure rate

  Using the cold knife method failed to remove the fibroids. During operative transfer to other surgical methods to remove submucosal fibroids, such as electrical cutting

  On the 1 day of surgery

• Incidence of complications

  hemorrhage, pneumonedema, or perforation were registered

  On the 1 day of surgery and on 1 day after surgery

• surgical bleeding

  Through the intraoperative blood loss assessment and preoperative and postoperative hemoglobin comparison

  On the 1 day of surgery and on 1 day after surgery

• Checklist of symptom relief

  postoperative menstrual volume, menstrual period, anemia, postoperative fertility, postoperative intrauterine adhesions.

  followed-up at 3, 6，12，24 months after surgery

Study Arms (1)

The hysteroscopic myomectomy group

Patients underwent cold knife hysteroscopic myomectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who met the inclusion criteria and underwent cold knife hysteroscopic myomectomy in our hospital being included in the study.

You may qualify if:

• All patients who underwent cold knife hysteroscopic myomectomy and excised tissue that showed pathology confirmation of leiomyoma.

You may not qualify if:

• Patients has gynecologic malignancy.

Sponsors & Collaborators

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

Study Sites (1)

Xu Wanwan

Yiwu, Zhejiang, 322000, China

Location

Study Officials

• Wanwan Xu, Doctor

  The Fourth Affiliated Hospital Zhejiang University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 29, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): May 23, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)