Actively Recruiting

Age: 18Years - 60Years
FEMALE
ID06526962

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

Led by University of Cagliari · Updated on 2024-07-30

214

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two different surgical tools, a 5 Fr bipolar electrode and a 5 Fr angled conical optical fiber for a dual wavelength diode laser, to perform hysteroscopic polypectomy in an outpatient setting. The study aims to assess procedure time, use of additional instruments, procedure effectiveness and safety, sample quality for analysis, instrument suitability, patient pain and anxiety, and changes in quality of life after treatment for women with suspected small endometrial polyps. Participants will undergo a detailed medical evaluation and pelvic ultrasound before the procedure. During outpatient hysteroscopy without anesthesia, one of the two tools will be used for polypectomy. The procedure is performed using a vaginoscopic approach with saline distension and continuous video recording. The operator will evaluate the instrument's performance, and a pathologist will assess the tissue sample quality. Pain and anxiety will be measured 20 minutes after the procedure, and patients will be observed for 30 minutes before discharge. Follow-up occurs 60 days later with another pelvic ultrasound to check for residual tissue, repeated quality of life questionnaires, and assessment of any late complications. The study measures the time to complete the hysteroscopic procedure as the primary outcome while also tracking additional instrument use, lesion removal effectiveness, adverse events, tissue quantity, instrument suitability, pain, anxiety, and quality of life over time. Women aged 18 to 60 with small suspected single polyps and specific symptoms may participate.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and younger than 60 years
  • Suspicion of a single endometrial polyp less than 20 mm in size, confirmed by ultrasound
  • Presence of abnormal uterine bleeding or history of infertility (no conception after 12 months of unprotected intercourse)
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Presence of multiple endometrial polyps
  • Single endometrial polyp larger than 20 mm
  • Concurrent intrauterine fibroids, endometrial thickening, or adhesions
  • Use of anticoagulant drugs or Selective Estrogen Receptor Modulators within 3 months
  • Other known causes of vaginal or cervical bleeding
  • Suspected adnexal pathology
  • Confirmed diagnosis of endometrial cancer
  • Suspected or recent pelvic inflammation within 6 months
  • Presence of tight cervical canal stenosis
  • Need for anesthesia for the hysteroscopic procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo outpatient hysteroscopic polypectomy using one of two instruments: a 5Fr bipolar electrode or conical optical 5Fr fibers for dual wavelength diode laser. The procedure is performed without anesthesia or sedation in an outpatient setting. During the procedure, various clinical data including procedure duration, accessory instrumentation use, and any events or symptoms are recorded. Pain and anxiety levels are assessed 20 minutes after the procedure, followed by a 30-minute post-procedure observation period before discharge.

1 procedure visit with post-procedure assessment

Post-operative Follow-up

Duration - 60 days after procedure

Participants return approximately 60 days after the procedure for a follow-up visit. This visit includes a thorough pelvic ultrasound evaluation to check for residual formations, administration of a quality of life questionnaire, and recording of any late surgical complications.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

University of Cagliari

Cagliari, Italy, 09042

Actively Recruiting

Loading map...

Research Team

S

Salvatore Giovanni Vitale, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effectiveness of Hysteroscopic Techniques for Endometrial Polyp Removal: The Italian Multicenter Trial.

Massimo Luerti, Amerigo Vitagliano, Attilio Di Spiezio Sardo...

https://pubmed.ncbi.nlm.nih.gov/30528831

Is outpatient hysteroscopy accurate for the diagnosis of endometrial pathology among perimenopausal and postmenopausal women?

Shikma Bar-On, Alon Ben-David, Gilad Rattan...

https://pubmed.ncbi.nlm.nih.gov/28763396

Submucous myomas: a new presurgical classification to evaluate the viability of hysteroscopic surgical treatment--preliminary report.

Ricardo Bassil Lasmar, Paulo Roberto Mussel Barrozo, Rogério Dias...

https://pubmed.ncbi.nlm.nih.gov/16036188

Outpatient hysteroscopic polypectomy: bipolar energy system (Versapoint®) versus diode laser - randomized clinical trial.

Maria D Lara-Domínguez, Jose E Arjona-Berral, Rafaela Dios-Palomares...

https://pubmed.ncbi.nlm.nih.gov/26527251

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Erik von Elm, Douglas G Altman, Matthias Egger...

https://pubmed.ncbi.nlm.nih.gov/18313558