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

July 24, 2024 updated by: Salvatore Giovanni Vitale, University of Cagliari

Comparison Between Two Different Tools for Outpatient Hysteroscopic Polypectomy: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Cagliari, Italy, 09042
        • Recruiting
        • University of Cagliari
        • Contact:
        • Sub-Investigator:
          • Stefano Angioni, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients who undergo outpatient hysteroscopic polypectomy using 5Fr bipolar electrode
Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
Outpatient hysteroscopic polypectomy
Group B
Patients who undergo outpatient hysteroscopic polypectomy using a conical optical 5Fr fibers for dual wave-length diode laser
Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
Outpatient hysteroscopic polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to perform the operative hysteroscopic procedure.
Time Frame: 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).
End of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for supplementary instrumentation
Time Frame: End of procedure
The need for supplementary instrumentation to complete the procedure (e.g., 5 Fr cold blade scissors)
End of procedure
Effectiveness in removing the lesions
Time Frame: 60 days
Effectiveness of the procedure (absence/persistence of the lesion), documented by postoperative ultrasound evaluation performed 60 days after the procedure
60 days
Adverse events
Time Frame: 30 minutes
Adverse events related to the procedure (e.g., vagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and adjacent organs)
30 minutes
Quantity of resected tissue
Time Frame: 40 days
Adequacy of the resected material weight for histological examination (weight in grams)
40 days
Instrument Suitability
Time Frame: End of procedure
Overall suitability of the instrument used (in terms of its cutting and coagulation precision), as judged by the operating surgeon
End of procedure
Pain perception
Time Frame: 20 minutes
The level of pain perceived by the patient during the procedure, evaluated using the Visual Analog Scale (VAS, from a minimum value of 1 to a maximum value of 10, where 1 is the best outcome and 10 is the worst outcome)
20 minutes
Level of anxiety during the procedure
Time Frame: 20 minutes
Level of anxiety experienced by the patient during the procedure, evaluated using the Hospital Anxiety and Depression Scale (H.A.D.S.), from a minimum value of 0 to a maximum value of 21, where 0 is the best outcome and 21 is the worst outcome)
20 minutes
Patients' quality of life
Time Frame: 60 days
Changes in the patient's perceived quality of life 60 days after the procedure, evaluated using the EuroQol-5D questionnaire (EuroQol 5-dimension questionnaire, from a minimum value of 0 to a maximum value of 100, where 0 is the worst outcome and 100 is the best outcome).
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Estimated)

November 7, 2024

Study Completion (Estimated)

May 7, 2025

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYSTOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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