Clinical trial NCT06526962: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
Official title: Comparison Between Two Different Tools for Outpatient Hysteroscopic Polypectomy: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Polyp
Keywords: Hysteroscopy
Outpatient
Endometrial Polyp
Polypectomy
Dual Wave-Lenght Diode Laser
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy

Brief summary: 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.

Detailed description: 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.

In this study phase, endocavitary characterization of endometrial polyps will be performed based on their size, location, and relationship to the tubal ostia, as well as their consistency and implantation base characteristics. Patients will then undergo polypectomy using one of two possible instruments: a 5 Fr "twizzle" bipolar electrode or a 5 Fr angled conical optical fiber for a dual-wavelength diode laser. The choice of instrument for each operative procedure will be at the operator's discretion.

During the procedure, the operator will be assisted by two assistants: one will manage the instrumentation, and the other will record the time required for the procedure and any use of additional accessory instrumentation, following the operator's instructions. Additionally, the latter will document on a dedicated form any events or symptoms experienced by the patient during the procedure and the 30-minute post-procedure observation period. The performance of each instrument will be subjectively evaluated by the operator regarding its cutting and coagulation precision, using a numerical rating scale from 0 to 10, where 0 indicates the minimum value and 10 the maximum value (Numerical Rating Scale, NRS). Furthermore, the adequacy of the removed sample for histological investigation will be assessed by the pathologist using a similar numerical rating scale (0 to 10, where 0 indicates the minimum appropriateness and 10 the maximum). Elements that may characterize the sample's adequacy include sufficient tissue quantity, absence of crushing, tearing, or electrocution artifacts, and adequate fixation.

Twenty minutes after completing the hysteroscopy (T2), the patient's perception of pain and anxiety levels experienced during the procedure will be assessed. The intensity of perceived pain will be evaluated using the VAS Scale (with levels ranging from 0 to 10, where 0 refers to no pain, 1-3 mild pain, 4-7 moderate pain, 8-10 severe pain) and the McGill Pain Questionnaire (which investigates perceived pain levels across three dimensions: sensory, affective, and evaluative). Anxiety levels experienced during the procedure will be assessed using the Hospital Anxiety and Depression Scale (H.A.D.S.). If the postoperative course is regular, patients will be discharged 30 minutes after the hysteroscopy.

Each patient will then undergo a post-surgical follow-up (T3) 60 days after the procedure, during which a thorough pelvic ultrasound evaluation will be performed (using the same previously described methods) primarily to investigate the possible presence of residual formations. The EuroQol-5D questionnaire will be administered again, and any late surgical complications will be recorded on a dedicated evaluation form.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time required to perform the operative hysteroscopic procedure.
timeFrame: End of procedure
Secondary outcomes:
measure: Need for supplementary instrumentation
timeFrame: End of procedure
measure: Effectiveness in removing the lesions
timeFrame: 60 days
measure: Adverse events
timeFrame: 30 minutes
measure: Quantity of resected tissue
timeFrame: 40 days
measure: Instrument Suitability
timeFrame: End of procedure
measure: Pain perception
timeFrame: 20 minutes
measure: Level of anxiety during the procedure
timeFrame: 20 minutes
measure: Patients' quality of life
timeFrame: 60 days
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: University of Cagliari
Study officials:
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