5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
Recruiting
Observational Study
Endometrial Polyp
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 60
Sex
Female
Study type
Observational
Participants needed
214 (estimated)
Sponsor
University of Cagliari · Other
Who this trial is looking for
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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.
Trial Locations
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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 inter…
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.
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