An observational study in Retained Products of Conception, Hysteroscopy and Endometrial Polyp Benign, sponsored by Shaare Zedek Medical Center. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Shaare Zedek Medical Center · Observational
The goal of this observational study is to identify predictors of successful removal of benign intrauterine pathology using a mini-resectoscope during office operative hysteroscopy without anesthesia in adult women with suspected or diagnosed endometrial polyps or retained products of conception up to 2.5 cm in size.
The main questions it aims to answer are:
Participants will:
Office hysteroscopy has significantly evolved over the last decade with the development of smaller operative hysteroscopic systems that allow treatment of intrauterine pathology without cervical dilation, sedation, or general anesthesia. These advances support the transition from conventional operating-room hysteroscopy toward office-based "see-and-treat" procedures.
Despite increasing adoption of office operative hysteroscopy, patient selection remains insufficiently standardized. While many patients tolerate office procedures well, a subset experience severe pain, inability to complete the procedure, or technical difficulties related to cervical access, lesion characteristics, or prolonged operative duration. Current literature provides limited data regarding predictors of procedural success and patient tolerability, particularly in procedures performed using mini-resectoscope technology.
The mini-resectoscope system used in this study was designed specifically for office operative hysteroscopy and combines a reduced outer diameter with the ability to perform electrosurgical resection of intrauterine pathology. Compared with conventional resectoscopes, the smaller caliber may reduce the need for cervical dilation and improve feasibility in outpatient settings. However, evidence regarding optimal patient selection for this technology remains limited.
The present study focuses on women with suspected or confirmed benign intrauterine pathology, specifically endometrial polyps and retained products of conception measuring up to 2.5 cm. These lesions are among the most common indications for operative hysteroscopy and are frequently encountered in outpatient hysteroscopy clinics.
A major objective of the study is to identify demographic, gynecologic, clinical, and hysteroscopic characteristics associated with successful completion of office operative hysteroscopy without anesthesia. Variables evaluated in the study were selected based on previously suggested associations with procedural difficulty or pain perception. These include parity, menopausal status, prior cervical procedures, history of cesarean delivery, prior hysteroscopic interventions, uterine orientation, cervical stenosis, lesion morphology, lesion vascularity, and operative duration.
Pain assessment is an important component of the study because procedural pain remains one of the primary limitations of office operative hysteroscopy. Pain severity will be assessed using the Visual Analog Scale (VAS), a validated and widely used instrument for procedural pain evaluation. Both intraoperative pain and early postoperative pain will be recorded to better characterize immediate patient tolerability.
The study is designed as a prospective observational single-arm investigation performed in a dedicated outpatient hysteroscopy clinic. All procedures will be performed by experienced hysteroscopists using a standardized office-based approach without anesthesia. Procedure completion, technical difficulty, operative duration, and causes of incomplete procedures will be systematically documented.
The investigators hypothesize that successful office treatment can be achieved in the majority of appropriately selected patients, while severe pain will remain limited to a minority of cases. The study additionally aims to evaluate whether prolonged operative duration is associated with increased pain scores and whether pathology type influences procedural feasibility.
Identification of predictors associated with successful and well-tolerated office hysteroscopy may contribute to the development of evidence-based patient selection criteria for office operative hysteroscopy using mini-resectoscope systems. Improved selection algorithms may reduce unnecessary exposure to general anesthesia, improve patient counseling, optimize outpatient workflow, and support wider implementation of minimally invasive office-based hysteroscopic treatment strategies.
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Adult women presenting to the hysteroscopy clinic within the Gynecology Department at Shaare Zedek Medical Center who are referred for evaluation and management of suspected or confirmed benign intrauterine pathology. Patients are evaluated in an outpatient hysteroscopy setting and may be offered office operative hysteroscopy using a mini-resectoscope as part of routine clinical care when considered appropriate by the treating hysteroscopist
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Exclusion Criteria:
Adult women with suspected or confirmed benign intrauterine pathology, including endometrial polyps or retained products of conception up to 2.5 cm in size, undergoing office operative hysteroscopy without anesthesia using a mini-resectoscope system. Participants will undergo hysteroscopic removal of the intrauterine pathology in an outpatient clinic setting and will complete pain assessment using the Visual Analog Scale (VAS) during and after the procedure. Demographic, gynecologic, clinical, hysteroscopic, and procedural variables will be prospectively collected to evaluate predictors of procedural success and pain severity
Device: Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia
Office operative hysteroscopy performed without anesthesia using the Karl Storz Mini-Resectoscope system (outer diameter approximately 5.5 mm) for hysteroscopic removal of benign intrauterine pathology, including endometrial polyps and retained products of conception up to 2.5 cm in size. Procedures are performed in an outpatient hysteroscopy clinic using a see-and-treat approach without routine cervical dilation, sedation, or general anesthesia. Intraoperative procedural characteristics, procedure duration, procedural completion, and patient-reported pain scores using the Visual Analog Scale (VAS) are prospectively recorded.
Number of Participants With Complete Removal of Intrauterine Pathology During Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia
Procedural success defined as complete hysteroscopic removal of the intrauterine pathology (endometrial polyp or retained products of conception) using the Karl Storz Mini-Resectoscope during office operative hysteroscopy without anesthesia.
Time frame: During the procedure
Comparison of Rates of Incomplete Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope According to Patient's Characteristics
The rates of incomplete office operative hysteroscopy without anesthesia will be compared according to the patient's demographic, obstetric, gynecologic, and procedural characteristics, including age, body mass index (BMI), parity, prior vaginal deliveries, prior cesarean deliveries, menopausal status, previous hysteroscopic or gynecologic procedures, cervical stenosis, uterine orientation, lesion characteristics, and procedure duration. Reasons for procedural failure, including severe pain or discomfort, bleeding impairing visualization, technical difficulty, or incomplete lesion resection, will also be documented.
Time frame: During the procedure
Intraoperative Visual Analog Scale (VAS) Pain Score During Office Operative Hysteroscopy
Average Intraoperative Visual Analog Scale (VAS) Pain Score During Office Operative Hysteroscopy
Time frame: During the procedure
Postoperative Pain Severity Assessed by Visual Analog Scale (VAS)
Average patient-reported pain measured 5 minutes after completion of the hysteroscopic procedure using the Visual Analog Scale (VAS; range 0-10).
Time frame: 5 minutes after the procedure
Procedure Duration
Total operative time of office operative hysteroscopy using the mini-resectoscope, measured in minutes from insertion of the hysteroscope into the uterine cavity until completion of the procedure.
Time frame: During the procedure
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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