About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial population
Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy
Trial design
Case-control
Prospective
Treatments tested in this trial
5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
DeviceOutpatient hysteroscopic polypectomy
Treatment groups
Trial outcomes
Primary outcomes
Time required to perform the operative hysteroscopic 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).
Secondary outcomes
Need for supplementary instrumentation
The need for supplementary instrumentation to complete the procedure (e.g., 5 Fr cold blade scissors)
Effectiveness in removing the lesions
Effectiveness of the procedure (absence/persistence of the lesion), documented by postoperative ultrasound evaluation performed 60 days after the procedure
Adverse events
Adverse events related to the procedure (e.g., vagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and adjacent organs)
Quantity of resected tissue
Adequacy of the resected material weight for histological examination (weight in grams)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.