Development and Preliminary Clinical Evaluation of a Multifunctional Operative Support Arm in Reproductive Laparoscopic Surgery: A Randomized Controlled Study.

OBJECTIVE

To evaluate short-term clinical outcomes, surgeon-reported fatigue, and staff user experience associated with a multifunctional operative support arm in reproductive laparoscopic surgery.

DESIGN

Single-center, parallel-group randomized controlled trial.

SETTING

Tertiary university-affiliated reproductive medicine center.

PATIENTS: One hundred women aged 25-40 years undergoing laparoscopic surgery for stage I pelvic endometriosis, hydrosalpinx, or benign ovarian cysts.

INTERVENTIONS: Participants were randomized to surgery using the multifunctional operative support arm or a conventional passive support condition.

MAIN OUTCOME MEASURES: The primary outcome was surgeon-reported fatigue assessed using a 0-10 visual analog scale. Secondary outcomes included staff satisfaction and device-related comfort. Clinical outcomes included operative duration, postoperative infection, length of stay, anti-Müllerian hormone, and antral follicle count.

RESULTS

Baseline characteristics were comparable between groups. Operative duration, length of stay, postoperative infection, and ovarian reserve indicators did not differ significantly. Mixed-effects analysis of 550 surgeon and 450 nurse evaluations showed lower surgeon fatigue with the device than with conventional support (-0.66, 95% CI -0.78 to -0.54; p < 0.001). Ventilation, temperature control, and comfort scores were also higher, although satisfaction differences were small.

CONCLUSION

The device improved staff-reported ergonomic comfort without adverse short-term clinical effects, but confirmation with objective measures is needed.