Three-dimensional printing model-assisted single-port laparoscopic multiple myomectomy: a randomized controlled trial

Multiple uterine fibroids present significant surgical challenges in single-port laparoscopic myomectomy, particularly regarding optimal removal sequence and surgical planning. Three-dimensional (3D) printing technology offers potential advantages for preoperative planning and intraoperative guidance. We conducted a single-center, randomized controlled trial comparing 3D printing model-assisted single-port laparoscopic myomectomy with conventional surgery in women with multiple uterine fibroids. The primary endpoints were total operative time and estimated blood loss. Secondary endpoints included surgeon workload assessment using the NASA Task Load Index (NASA-TLX), patient satisfaction, surgical complications, and long-term follow-up outcomes including fibroid residual and recurrence rates. Patients were randomly assigned 1:1 to receive either 3D model-assisted surgery or conventional surgery using computer-generated randomization with concealed allocation. Sample size was calculated based on an expected 20-minute reduction in operative time with 80% power and α = 0.05. Of 140 patients assessed for eligibility, 133 were randomized and 110 completed the per-protocol analysis (55 in each group). In the per-protocol analysis of 110 patients, the 3D model group had significantly shorter total operative time (mean difference, 25.7 min; 95% confidence interval [CI], 17.7 to 33.7; P = 0.001) and modestly reduced estimated blood loss (mean difference, 24.4 ml; 95% CI, 5.1 to 43.7; P = 0.050). The 3D model group also showed significant improvements in surgeon workload scores (mean difference, 10.1 points; 95% CI, 6.7 to 13.6; P < 0.001) and patient satisfaction (mean difference, 1.8 points; 95% CI, 1.5 to 2.1; P < 0.001). Hospital stay duration was similar between groups (4.5 ± 0.3 vs. 4.4 ± 0.3 days; P = 0.100). At 1-year follow-up, fibroid recurrence rates were lower in the 3D model group (1.8% vs. 12.7%; P = 0.060), and immediate postoperative residual fibroid rates were reduced (1.8% vs. 7.3%; P = 0.363). No conversions to open surgery occurred in either group, and complication rates were similar (5.5% vs. 14.5%; P = 0.202). Surgical plan adherence analysis demonstrated significantly higher protocol adherence in the 3D model group (87.3% vs. 65.5% exact sequence match; P = 0.002). In this single-center trial, 3D printing model-assisted single-port laparoscopic myomectomy significantly improved surgical efficiency and reduced surgeon workload while maintaining excellent safety profiles. The 3D model group demonstrated significantly higher surgical plan adherence compared with conventional planning. While favorable trends were observed in fibroid residual and recurrence outcomes, these findings did not achieve statistical significance and should be interpreted as hypothesis-generating. These results require validation in multicenter trials before broader clinical implementation. Trial registration: This trial was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR) under the registration number ChiCTR2500112904, with the first registration on November 20, 2025 (https://www.chictr.org.cn/showproj.html?proj=287706).