Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
According to the inclusion and exclusion criteria，collecting the data of participants who have undergone cold knife hysteroscopic myomectomy. The investigators will analyze the safety and efficacy of cold knife hysteroscopic myomectomy through the collected data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| The hysteroscopic myomectomy group Patients underwent cold knife hysteroscopic myomectomy |
Outcome Measures
Primary Outcome Measures
- Success rate [On the 1 day of surgery]
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
- failure rate [On the 1 day of surgery]
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
- Incidence of complications [On the 1 day of surgery and on 1 day after surgery]
hemorrhage, pneumonedema, or perforation were registered
- surgical bleeding [On the 1 day of surgery and on 1 day after surgery]
Through the intraoperative blood loss assessment and preoperative and postoperative hemoglobin comparison
- Checklist of symptom relief [followed-up at 3, 6，12，24 months after surgery]
postoperative menstrual volume, menstrual period, anemia, postoperative fertility, postoperative intrauterine adhesions.
Eligibility Criteria
Criteria
Inclusion Criteria:
All patients who underwent cold knife hysteroscopic myomectomy and excised tissue that showed pathology confirmation of leiomyoma.
Exclusion Criteria:
Patients has gynecologic malignancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xu Wanwan | Yiwu | Zhejiang | China | 322000 |
Sponsors and Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Investigators
- Study Chair: Wanwan Xu, Doctor, The Fourth Affiliated Hospital Zhejiang University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K2023084