5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy

NCT ID: NCT06526962

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2025-05-07

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.

Conditions

Endometrial Polyp

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Patients who undergo outpatient hysteroscopic polypectomy using 5Fr bipolar electrode

5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser

Intervention Type: DEVICE

Outpatient hysteroscopic polypectomy

Group B

Patients who undergo outpatient hysteroscopic polypectomy using a conical optical 5Fr fibers for dual wave-length diode laser

5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser

Intervention Type: DEVICE

Outpatient hysteroscopic polypectomy

Interventions

5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser

Outpatient hysteroscopic polypectomy

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Salvatore Giovanni Vitale

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cagliari

Cagliari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Salvatore Giovanni Vitale, PhD

Role: CONTACT

salvatoreg.vitale@unica.it

3479354575

Facility Contacts

Salvatore Giovanni Vitale, PhD

Role: primary

salvatoreg.vitale@unica.it

3479354575

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Other Identifiers

HYSTOP

Identifier Type: -

Identifier Source: org_study_id