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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorUniversity of Cagliari

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser

    Device

    Outpatient hysteroscopic polypectomy

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: Group A1 intervention
Group B: Group B1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
End of procedure

Secondary outcomes

1

Need for supplementary instrumentation

The need for supplementary instrumentation to complete the procedure (e.g., 5 Fr cold blade scissors)

Time frame
End of procedure
2

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

Time frame
60 days
3

Adverse events

Adverse events related to the procedure (e.g., vagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and adjacent organs)

Time frame
30 minutes
4

Quantity of resected tissue

Adequacy of the resected material weight for histological examination (weight in grams)

Time frame
40 days

Other outcomes

Sponsors and contacts

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