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Trial Title:
Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments
NCT ID:
NCT06150521
Condition:
Hysteroscopic Myomectomy
Conditions: Official terms:
Myoma
Conditions: Keywords:
Hysteroscopy
Cold knife
Myomectomy
Submucous myoma
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
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.
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.
Criteria for eligibility:
Study pop:
Women who met the inclusion criteria and underwent cold knife hysteroscopic myomectomy in
our hospital being included in the study.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Xu Wanwan
Address:
City:
Yiwu
Zip:
322000
Country:
China
Start date:
May 23, 2023
Completion date:
May 23, 2026
Lead sponsor:
Agency:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Agency class:
Other
Source:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150521
