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Development and Preliminary Clinical Evaluation of a Multifunctional Operative Support Arm in Reproductive
Wenying Mao1, Nan Lu1,2
1Department of Reproductive Medicine, Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University), Nanjing, Jiangsu, China.
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.
