Comparing two surgical instruments for removing endometrial polyps
Comparison Between Two Different Tools for Outpatient Hysteroscopic Polypectomy: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser
University of Cagliari · NCT06526962
This study is testing which of two surgical tools is better and safer for removing endometrial polyps in women having the procedure done in an outpatient setting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | University of Cagliari (other) |
| Locations | 1 site (Cagliari) |
| Trial ID | NCT06526962 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness and safety of two surgical instruments, a 5 Fr bipolar electrode and a 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting. The study will evaluate various parameters including procedure duration, effectiveness, safety, and patient-reported pain and anxiety levels. Participants will undergo a thorough medical evaluation and pelvic ultrasound before the procedure, and their characteristics will be recorded for analysis. The study is conducted at the Obstetrics and Gynecology Clinic of the University Hospital 'Duilio Casula' in Monserrato, Italy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 60 with a single endometrial polyp under 20 mm and experiencing abnormal uterine bleeding or infertility.
Not a fit: Patients with multiple endometrial polyps, larger polyps, or other complicating factors such as endometrial cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient experiences during hysteroscopic polypectomy.
How similar studies have performed: While similar studies have explored various surgical instruments for polypectomy, this specific comparison of bipolar electrodes and optical fibers for dual wavelength lasers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cagliari
- University of Cagliari — Cagliari, Italy (RECRUITING)
Study contacts
- Study coordinator: Salvatore Giovanni Vitale, PhD
- Email: salvatoreg.vitale@unica.it
- Phone: 3479354575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Polyp, Hysteroscopy, Outpatient, Polypectomy, Dual Wave-Lenght Diode Laser