Posted: Friday, March 17, 2023
Sophia Liff Maibom, MD, of the University of Copenhagen, and colleagues aim to investigate the feasibility of conducting a single-center, double-blind, randomized study comparing open versus robot-assisted laparoscopic radical cystectomy with intracorporeal urinary diversion in an enhanced recovery after surgery setup for patients with bladder cancer. The methodology of their proposed protocol was published in the journal Pilot and Feasibility Studies. Although the investigators acknowledge that blinding of surgical procedures is challenging for both patients and physicians, they believe that lessons can be learned from such a trial that may prove useful for designing and conducting future trials.
“We believe a blinded trial with a strict enhanced recovery after surgery setup protocol in radical cystectomy is necessary to further understand the true differences between robot-assisted laparoscopic radical cystectomy and open radical cystectomy,” the authors noted.
The study aimed to recruit 50 patients with nonmetastatic high-risk non–muscle-invasive or muscle-invasive bladder cancer who are scheduled for cystectomy at Copenhagen University Hospital. Participants and postoperative-caring physicians and nurses are blinded using a prestudy-designed abdominal dressing and blinding of the patient’s electronic health record.
The primary aim of the study is to analyze the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. The 11 secondary endpoints to be assessed follow: length of stay, days alive and out of the hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate or severe postanesthesia care unit complications, and presence of delirium.
The study authors reported that the success of the study’s blinding will depend on two aspects. First, the amount of “intentional” unblinding during admission to the hospital would reveal the method of surgery used on the patient. Second, “unintentional” unblinding can happen if variables that reveal the used procedure are not masked, such as the surgical wound on the patient’s abdomen.
Disclosures: The study authors reported no conflicts of interest.