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

Launched by UNIVERSITY OF CAGLIARI · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two different tools used in a minimally invasive surgery called hysteroscopic polypectomy, which is performed to remove growths called endometrial polyps from the uterus. The trial will look at the effectiveness of a 5 Fr bipolar electrode versus a 5 Fr angled conical optical fiber that uses a special laser. The goal is to find out which tool works better for this procedure, which is done in an outpatient setting, meaning you can go home the same day.

To participate in this study, women aged between 18 and 60 who have a suspected single endometrial polyp (less than 20 mm in size) and are experiencing abnormal bleeding or have a history of infertility may be eligible. Participants will undergo the procedure using one of the two tools being tested and can expect to be part of a study that aims to improve treatment options for endometrial polyps. It’s important to note that women with multiple polyps, larger polyps, or certain other medical conditions may not qualify for this trial. If you think you might be eligible or are interested in participating, discussing this with your doctor can provide more personalized information.

Gender

FEMALE

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.