A prospective non-randomized controlled study of a flexible panoramic electronic hysteroscope in outpatient hysteroscopic diagnosis and treatment.

OBJECTIVE

This study aims to evaluate the clinical efficacy of a novel endoscopic device-a flexible panoramic electronic hysteroscope-in outpatient hysteroscopic examinations and procedures.

METHODS

A prospective, non-randomized controlled study was conducted. A total of 60 patients who underwent outpatient hysteroscopy at the Department of Gynecology, International Peace Maternity and Child Health Hospital between October 30, 2024, and September 30, 2025, were enrolled. Among them, 30 patients were examined using the novel flexible panoramic electronic hysteroscope (study group), and the other 30 received conventional rigid hysteroscopy (control group). The two groups were compared in terms of examination time, intraoperative blood loss, adverse events, image quality, postoperative pain scores, patient satisfaction, operator-rated device performance, and operator satisfaction to assess the practical value of the novel hysteroscope.

RESULTS

All procedures were completed under general anesthesia. Compared with the control group, the study group demonstrated significantly higher image quality (P < 0.01), lower postoperative pain scores (VAS) [30 min: (1.47 ± 0.51) vs. (2.43 ± 0.50); 60 min: (1.33 ± 0.48) vs. (2.27 ± 0.52); P < 0.01], and significantly higher patient satisfaction [30 min: 4.0 (4.0, 4.0) vs. 3.0 (3.0, 4.0); 60 min: 5.0 (4.0, 5.0) vs. 3.5 (3.25, 4.0); P < 0.01]. The difference in the rate of agreement with clinical diagnostic requirements between the study group and the control group was -3.33%, with the one-sided lower limit of the 95% confidence interval for the rate difference being -8.72%, which was greater than the non-inferiority margin (-10%). No statistically significant differences were observed between the two groups in examination time (min) [(7.62 ± 1.18) vs. (7.41 ± 1.23)], intraoperative blood loss (mL) [(12.50 ± 1.43) vs. (13.00 ± 0.91)], or operator-rated device performance and satisfaction (P > 0.05).

CONCLUSION

The flexible panoramic electronic hysteroscope demonstrates high safety and efficacy in outpatient hysteroscopy, reducing patient pain and improving patient satisfaction, thereby showing promising clinical applicability.