An observational study in Endometrial Polyp, sponsored by University of Cagliari. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by University of Cagliari · Observational
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.
More specifically, the study aims to compare these instruments by evaluating the following parameters:
A prospective observational study will be conducted at the Obstetrics and Gynecology Clinic of the University Hospital "Duilio Casula" in Monserrato (Italy), following the approval of the study design by the Ethics Committee. Women who meet the inclusion and exclusion criteria will undergo a thorough medical history and gynecological clinical evaluation before performing diagnostic and operative hysteroscopy (T0). The characteristics of the participants, including age, ethnicity, weight, height, lifestyle habits, and medication use, will be recorded in a dedicated database. Each patient will be assigned an ID, which will serve as the patient's unique identifier.
Before performing the hysteroscopic procedure, each patient recruited for the study (T0) will undergo a thorough pelvic ultrasound evaluation using a transvaginal probe by an experienced sonographer (at least 500 procedures performed) according to standard protocols to evaluate the ultrasonographic characteristics of the endometrial polyp. Specifically, the location, size, echostructure, and vascular pattern will be carefully assessed and recorded. During the recruitment phase (T0), the EuroQol-5D questionnaire will be administered to determine the impact of symptoms related to the presence of the lesion on the patient's perceived quality of life. The Italian version of the EuroQol-5D questionnaire, validated by the EuroQoL Group, will be used for this study.
All recruited patients will then undergo diagnostic and operative hysteroscopy (T1) in an outpatient setting without any anesthesia/sedation or pharmacological/mechanical cervical preparation, using a 5 mm continuous flow Bettocchi rigid hysteroscope with a 5 Fr (1.67 mm) working channel and 30° optics (Karl Storz SE \& Co. KG, Tuttlingen, Germany), performed by the same experienced operator (at least 500 procedures performed). The procedures will be carried out using a vaginoscopic approach. Uterine cavity distension will be achieved using saline solution, delivered by an electronic irrigation/aspiration pump (Endomat, Karl Storz SE \& Co. KG, Tuttlingen, Germany), maintaining an intracavitary pressure ≤ 50 mmHg and an intrauterine flow ≤ 300 mL/min. Illumination will be provided by a 300 W Xenon light source. Images will be displayed on a high-resolution color monitor using an integrated circuit camera, and all procedures will be video recorded from the introduction of the hysteroscope until its extraction.
In this study phase, endocavitary characterization of endometrial polyps will be performed based on their size, location, and relationship to the tubal ostia, as well as their consistency and implantation base characteristics. Patients will then undergo polypectomy using one of two possible instruments: a 5 Fr "twizzle" bipolar electrode or a 5 Fr angled conical optical fiber for a dual-wavelength diode laser. The choice of instrument for each operative procedure will be at the operator's discretion.
During the procedure, the operator will be assisted by two assistants: one will manage the instrumentation, and the other will record the time required for the procedure and any use of additional accessory instrumentation, following the operator's instructions. Additionally, the latter will document on a dedicated form any events or symptoms experienced by the patient during the procedure and the 30-minute post-procedure observation period. The performance of each instrument will be subjectively evaluated by the operator regarding its cutting and coagulation precision, using a numerical rating scale from 0 to 10, where 0 indicates the minimum value and 10 the maximum value (Numerical Rating Scale, NRS). Furthermore, the adequacy of the removed sample for histological investigation will be assessed by the pathologist using a similar numerical rating scale (0 to 10, where 0 indicates the minimum appropriateness and 10 the maximum). Elements that may characterize the sample's adequacy include sufficient tissue quantity, absence of crushing, tearing, or electrocution artifacts, and adequate fixation.
Twenty minutes after completing the hysteroscopy (T2), the patient's perception of pain and anxiety levels experienced during the procedure will be assessed. The intensity of perceived pain will be evaluated using the VAS Scale (with levels ranging from 0 to 10, where 0 refers to no pain, 1-3 mild pain, 4-7 moderate pain, 8-10 severe pain) and the McGill Pain Questionnaire (which investigates perceived pain levels across three dimensions: sensory, affective, and evaluative). Anxiety levels experienced during the procedure will be assessed using the Hospital Anxiety and Depression Scale (H.A.D.S.). If the postoperative course is regular, patients will be discharged 30 minutes after the hysteroscopy.
Each patient will then undergo a post-surgical follow-up (T3) 60 days after the procedure, during which a thorough pelvic ultrasound evaluation will be performed (using the same previously described methods) primarily to investigate the possible presence of residual formations. The EuroQol-5D questionnaire will be administered again, and any late surgical complications will be recorded on a dedicated evaluation form.
312 studies on the registry are indexed under Polyps; 60 are open to participants now.
This study's planned enrollment of 214 is close to the median of 209 across 101 observational studies indexed under Polyps.
Browse Polyps studies →University of Cagliari is the lead sponsor of 85 studies on the registry; 17 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who undergo outpatient hysteroscopic polypectomy using 5Fr bipolar electrode
Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
Patients who undergo outpatient hysteroscopic polypectomy using a conical optical 5Fr fibers for dual wave-length diode laser
Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
Outpatient hysteroscopic polypectomy
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
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
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
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
Quantity of resected tissue
Adequacy of the resected material weight for histological examination (weight in grams)
Time frame: 40 days
Instrument Suitability
Overall suitability of the instrument used (in terms of its cutting and coagulation precision), as judged by the operating surgeon
Time frame: End of procedure
Pain perception
The level of pain perceived by the patient during the procedure, evaluated using the Visual Analog Scale (VAS, from a minimum value of 1 to a maximum value of 10, where 1 is the best outcome and 10 is the worst outcome)
Time frame: 20 minutes
Level of anxiety during the procedure
Level of anxiety experienced by the patient during the procedure, evaluated using the Hospital Anxiety and Depression Scale (H.A.D.S.), from a minimum value of 0 to a maximum value of 21, where 0 is the best outcome and 21 is the worst outcome)
Time frame: 20 minutes
Patients' quality of life
Changes in the patient's perceived quality of life 60 days after the procedure, evaluated using the EuroQol-5D questionnaire (EuroQol 5-dimension questionnaire, from a minimum value of 0 to a maximum value of 100, where 0 is the worst outcome and 100 is the best outcome).
Time frame: 60 days
Plan to share: Undecided
Started May 2024 (actual). Primary completion is estimated for Nov 2024, 6 months after the start.
Of 51 non-industry observational studies under Polyps, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's planned 6 months is below that.
Counting every sponsor, half of 58 studies reached it within 30 months; a quarter within 11 and three quarters within 58.
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University of Cagliari