Office Operative Hysteroscopy: An Update.
Christina Alicia Salazar, Keith B Isaacson
https://pubmed.ncbi.nlm.nih.gov/28803811Actively Recruiting
Led by University of Cagliari · Updated on 2024-07-30
214
Participants Needed
1
Research Sites
25 weeks
Total Duration
Researchers are comparing two different surgical tools, a 5 Fr bipolar electrode and a 5 Fr angled conical optical fiber for a dual wavelength diode laser, to perform hysteroscopic polypectomy in an outpatient setting. The study aims to assess procedure time, use of additional instruments, procedure effectiveness and safety, sample quality for analysis, instrument suitability, patient pain and anxiety, and changes in quality of life after treatment for women with suspected small endometrial polyps. Participants will undergo a detailed medical evaluation and pelvic ultrasound before the procedure. During outpatient hysteroscopy without anesthesia, one of the two tools will be used for polypectomy. The procedure is performed using a vaginoscopic approach with saline distension and continuous video recording. The operator will evaluate the instrument's performance, and a pathologist will assess the tissue sample quality. Pain and anxiety will be measured 20 minutes after the procedure, and patients will be observed for 30 minutes before discharge. Follow-up occurs 60 days later with another pelvic ultrasound to check for residual tissue, repeated quality of life questionnaires, and assessment of any late complications. The study measures the time to complete the hysteroscopic procedure as the primary outcome while also tracking additional instrument use, lesion removal effectiveness, adverse events, tissue quantity, instrument suitability, pain, anxiety, and quality of life over time. Women aged 18 to 60 with small suspected single polyps and specific symptoms may participate.
CONDITIONS
5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo outpatient hysteroscopic polypectomy using one of two instruments: a 5Fr bipolar electrode or conical optical 5Fr fibers for dual wavelength diode laser. The procedure is performed without anesthesia or sedation in an outpatient setting. During the procedure, various clinical data including procedure duration, accessory instrumentation use, and any events or symptoms are recorded. Pain and anxiety levels are assessed 20 minutes after the procedure, followed by a 30-minute post-procedure observation period before discharge.
1 procedure visit with post-procedure assessment
Duration - 60 days after procedure
Participants return approximately 60 days after the procedure for a follow-up visit. This visit includes a thorough pelvic ultrasound evaluation to check for residual formations, administration of a quality of life questionnaire, and recording of any late surgical complications.
1 follow-up visit (in-person)
Total: 1 location
1
University of Cagliari
Cagliari, Italy, 09042
Actively Recruiting
S
Salvatore Giovanni Vitale, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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