Viewing Study NCT06526962



Ignite Creation Date: 2024-10-25 @ 7:49 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06526962
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-16

Brief Title: 5Fr Bipolar Electrode vs Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
Sponsor: None
Organization: None

Study Overview

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
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HYSTOP
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 patients 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 patients 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 patients 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 anesthesiasedation or pharmacologicalmechanical cervical preparation using a 5 mm continuous flow Bettocchi rigid hysteroscope with a 5 Fr 167 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 irrigationaspiration pump Endomat Karl Storz SE Co KG Tuttlingen Germany maintaining an intracavitary pressure 50 mmHg and an intrauterine flow 300 mLmin 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 operators 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 operators 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 samples adequacy include sufficient tissue quantity absence of crushing tearing or electrocution artifacts and adequate fixation

Twenty minutes after completing the hysteroscopy T2 the patients 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 HADS 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None