Comparison Between Two Different Tools for Outpatient Hysteroscopic Polypectomy: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Time required to perform the operative hysteroscopic procedure.
研究概览
简要总结
The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting.
详细描述
More specifically, the study aims to compare these instruments by evaluating the following parameters:
- Duration of the procedure;
- Use of any additional accessory instrumentation;
- Effectiveness of the procedure;
- Safety of the procedure;
- Adequacy of the operative specimen for histological analysis;
- Overall suitability of the instrument used;
- Levels of pain and anxiety perceived by the patient during the procedure;
- Changes in the patient's quality of life related to the persistence or resolution of symptoms following the procedure.
A prospective observational study will be conducted at the Obstetrics and Gynecology Clinic of the University Hospital "Duilio Casula" in Monserrato (Italy), following the approval of the study design by the Ethics Committee. Women who meet the inclusion and exclusion criteria will undergo a thorough medical history and gynecological clinical evaluation before performing diagnostic and operative hysteroscopy (T0). The characteristics of the participants, including age, ethnicity, weight, height, lifestyle habits, and medication use, will be recorded in a dedicated database. Each patient will be assigned an ID, which will serve as the patient's unique identifier.
Before performing the hysteroscopic procedure, each patient recruited for the study (T0) will undergo a thorough pelvic ultrasound evaluation using a transvaginal probe by an experienced sonographer (at least 500 procedures performed) according to standard protocols to evaluate the ultrasonographic characteristics of the endometrial polyp. Specifically, the location, size, echostructure, and vascular pattern will be carefully assessed and recorded. During the recruitment phase (T0), the EuroQol-5D questionnaire will be administered to determine the impact of symptoms related to the presence of the lesion on the patient's perceived quality of life. The Italian version of the EuroQol-5D questionnaire, validated by the EuroQoL Group, will be used for this study.
All recruited patients will then undergo diagnostic and operative hysteroscopy (T1) in an outpatient setting without any anesthesia/sedation or pharmacological/mechanical cervical preparation, using a 5 mm continuous flow Bettocchi rigid hysteroscope with a 5 Fr (1.67 mm) working channel and 30° optics (Karl Storz SE & Co. KG, Tuttlingen, Germany), performed by the same experienced operator (at least 500 procedures performed). The procedures will be carried out using a vaginoscopic approach. Uterine cavity distension will be achieved using saline solution, delivered by an electronic irrigation/aspiration pump (Endomat, Karl Storz SE & Co. KG, Tuttlingen, Germany), maintaining an intracavitary pressure ≤ 50 mmHg and an intrauterine flow ≤ 300 mL/min. Illumination will be provided by a 300 W Xenon light source. Images will be displayed on a high-resolution color monitor using an integrated circuit camera, and all procedures will be video recorded from the introduction of the hysteroscope until its extraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years and < 60 years;
- •suspicion of a single endometrial polyp, documented by ultrasound, with dimensions less than 20 mm;
- •presence of abnormal uterine bleeding or history of infertility (defined as absence of conception after 12 months of regular unprotected intercourse aimed at conception);
- •consent to participate in the study.
排除标准
- •presence of multiple endometrial polyps;
- •presence of a single endometrial polyp with dimensions greater than 20 mm;
- •concurrent presence of intrauterine fibroids, focal or diffuse endometrial thickening, and/or intrauterine adhesions (synechiae);
- •current or recent use (< 3 months) of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
- •presence of another known cause of vaginal/cervical bleeding;
- •suspected adnexal pathology;
- •confirmed diagnosis of endometrial cancer;
- •suspected acute pelvic inflammation or recent history of pelvic inflammation (< 6 months);
- •presence of tight cervical canal stenosis;
- •requirement for any type of anesthesia to perform the hysteroscopic procedure.
结局指标
主要结局
Time required to perform the operative hysteroscopic procedure.
时间窗: End of procedure
The time required to perform the operative hysteroscopic procedure, which will be measured in seconds from the entry into the uterine cavity until the completion of the procedure, defined as the complete resection of the lesion (excluding the time related to the extraction of the resected material).
次要结局
- Instrument Suitability(End of procedure)
- Need for supplementary instrumentation(End of procedure)
- Effectiveness in removing the lesions(60 days)
- Adverse events(30 minutes)
- Quantity of resected tissue(40 days)
- Pain perception(20 minutes)
- Level of anxiety during the procedure(20 minutes)
- Patients' quality of life(60 days)
研究者
Salvatore Giovanni Vitale
Professor
University of Cagliari