Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07875985

Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope

Sponsor: Shaare Zedek Medical Center

View on ClinicalTrials.gov

Summary

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: * Which demographic, gynecologic, clinical, and hysteroscopic factors are associated with successful completion of office operative hysteroscopy using a mini-resectoscope without anesthesia? * Which factors are associated with severe pain during the procedure, defined as a Visual Analog Scale (VAS) score greater than 7? * Is prolonged procedure duration (\>3 minutes) associated with higher intraoperative pain scores? * Are there differences in success rates between procedures performed for endometrial polyps versus retained products of conception? Participants will: * Undergo office operative hysteroscopy without anesthesia using the Miniresectoscope device for removal of endometrial polyps or retained products of conception. * Provide demographic, obstetric, gynecologic, and medical history information before the procedure. * Have intraoperative hysteroscopic and surgical characteristics recorded, including cervical stenosis, uterine orientation, lesion size and location, lesion morphology, and procedure duration. * Complete pain assessments using the Visual Analog Scale (VAS) during the procedure and 5 minutes after the procedure. * Be evaluated for procedural success, defined as complete removal of the intrauterine pathology.

Official title: Predictors of Successful Removal of Benign Intrauterine Pathologies Using a Mini-Resectoscope During Office Operative Hysteroscopy Without Anesthesia: A Prospective Observational Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-10-01

Completion Date

2027-12-01

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Department of Gynecology, Shaare Zedek Medical Center

Jerusalem, Israel