The one-arm, non-randomized, one/two-stage phase II designs have been a mainstay in oncology trials for evaluating response rates or similar variants (i.e., tests about single proportions). With the goal of screening new therapies that have the potential to move into a randomized phase III trial or a subsequent randomized phase II trial, all while maintaining a logistically feasible sample size. However, since the implementation of the Food and Drug Administration's Fast Track Designation, there has been a trend toward randomized phase II clinical trials as a source of stronger evidence for those seeking fasttrack approvals. While there are many single-and multi-stage randomized designs for evaluating proportions in this phase II setting, there still exist limitations in terms of sample size (which directly impacts cost and study duration) or operating characteristics (ex. maintained type I error). In this article, we propose a new test for comparing two binomial proportions, which is a modification across existing methods (the standard z-test and Jung's test). This approach is contrasted with existing methods via numeric evaluation and further contrasted using a real-world oncology trial. The proposed method demonstrates improvements in efficiency and robustness against deviations from design assumptions. When applied to the existing trial, significant savings with respect to cost and time are illustrated. Our proposed test for comparing binomial proportions provides an efficient and robust alternative in the randomized phase II oncology setting, especially when the control arm has a high rate.

P[0.000], intraoperative incision length [(2.7AE0.3)cm vs (12.8AE2.4)cm, P[0.000], and postoperative intestinal function recovery time [(36.0AE13.9)h vs (50.2AE18.4)h, P[0.001] between the two groups were found. Significant differences in VAS score on the first postoperative day [(2.1AE1.0) vs (3.8AE1.2), P[0.001], VAS score on the third day after surgery [(1.0AE1.0) vs (1.8AE1.2)，P[0.009], and postoperative analgesia time [(22.8AE14.6)h vs (37.2AE14.5)h，P[0.000] between the two groups were also found. There were significant differences in postoperative drainage tube indwelling time [(4.4AE1.5)d vs (5.9AE2.4)d, P[0.003],and postoperative hospital stay [(9.1AE2.0)d vs (11.0AE3.1)d, P[0.003] between the two groups. Complications occurred in 2 patients in the SA-LESS group, all of which were anastomotic leakage. In the open group, 9 patients had complications after operation. Among them, 4 patients had anastomotic leakage and 5 patients developed a wound infection. Significant difference was found in complication rates (x 2 [4.885, P[0.027). The total PSAQ of the SA-LESS group was lower than that of the open group at 3 months, 6 months and 1 year [(61.9AE8.7) vs (85.9AE8.3), P[0.000；(48.2AE6.4) vs (74.0AE8.2)，P[0.000；(37.5AE4.8) vs (64.9AE6.3), P[0.000]. The SA-LESS group was followed up for 24-90 months, and the open group was followed up for 28-91 months. All cases were followed up for B-ultrasound and IVU, and postoperative hydronephrosis was improved to varying degrees. All cases were followed up for cystoscopy and no ureteral reflux was seen.CONCLUSIONS: SA-LESS ureterovesical reimplantation using insertion method, can result in small trauma, rapid postoperative recovery, less complications, and better cosmetic results with stable, long-term postoperative effect, which is worthy of application in clinic.

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