NIPH Clinical Trials Search

MIE-ERAS-RARC Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Bladder cancer
Date of first enrollment	30/01/2026
Target sample size	45
Countries of recruitment
Study type	Interventional
Intervention(s)	Interventions for the ERAS group will be conducted in accordance with the study protocol, as described below. 1. Study explanation and initiation of the herbal medicine On the day of intervention initiation, a sub-investigator will provide an explanation based on the study information sheet and the ERAS information document (including a questionnaire). The explanation will cover preoperative preparation for surgery, including preoperative stoma-care training, exercise therapy, nutritional guidance, intraoperative and postoperative measures, and discharge goals. After the explanation, Ninjin'yoeito will be initiated. The dosage will follow the approved package insert. At approximately 2 weeks after initiation, a clinic visit and blood tests will be performed to confirm the absence of adverse events such as pseudoaldosteronism and hepatic dysfunction. If no CTCAE Grade 2 or higher adverse events are observed, Ninjin'yoeito will be continued until postoperative day 90. 2. Stoma-care education and collection of preoperative adherence After the ERAS explanation, a certified wound, ostomy, and continence nurse will provide an orientation for stoma care techniques. Stoma education will be delivered in multiple sessions as needed according to the patient's level of understanding, aiming for skill acquisition before surgery. Achievement of preoperative measures (including exercise and nutrition guidance) will be collected using a questionnaire administered at the time of admission for surgery. From the day of admission, rehabilitation will be initiated and assessed, and discharge support will be provided. 3. Preoperative bowel preparation and fasting and carbohydrate loading No special mechanical bowel preparation will be performed preoperatively. On the day before surgery, patients will take a low-residue diet, and fasting will begin 6 hours before induction of general anesthesia. After intake of a carbohydrate beverage (Arginaid Water), patients will refrain from oral fluids starting 2 hours before induction of general anesthesia. 4. Analgesia and perioperative fluid management For intraoperative and postoperative analgesia, epidural anesthesia and scheduled administration of acetaminophen and NSAIDs will be used. Opioid use will be minimized as much as possible. Excessive perioperative fluid administration will be avoided. Intravenous fluid volume will be adjusted according to hemodynamics and fluid balance, with appropriate use of vasopressors as needed (target fluid rate is 3 mL per kg per hour or less). 5. Temperature management Active warming will be implemented intraoperatively to prevent hypothermia and thereby reduce delayed recovery associated with low body temperature. 6. Early postoperative care including tube removal, mobilization, and early feeding The nasogastric tube will be removed immediately after surgery. At 3 hours postoperatively, after confirming vital signs, the patient will be placed in a sitting position and instructed to chew gum for 5 minutes. If gum chewing is tolerated, oral water intake will be resumed. From postoperative day 1, oral intake will be initiated along with laxatives (magnesium oxide and Daikenchuto), and early and active mobilization will be promoted. 7. Antibiotic administration at ureteral stent removal At the time of ureteral stent removal, antibiotics will be administered based on the results of a urine culture submitted in advance. 8. Imaging and follow-up assessments Evaluations including CT will be performed preoperatively (before and after initiation of preoperative chemotherapy) and at 1 month and 3 months postoperatively. 9. Individualization for safety All interventions will be implemented with careful attention to patient safety and may be individually adjusted at each time point according to the patient's general condition.

Outcome(s)

Primary Outcome

Length of Stay; LOS

Secondary Outcome

Postoperative complications of Clavien-Dindo classification grade II or higher and their incidence within 30 days Postoperative complications of Clavien-Dindo classification grade III or higher and their incidence within 30 days Readmission rate due to postoperative complications within 90 days Barthel Index (BI): preoperatively, postoperative day (POD) 1, POD 3 plus or minus 1, POD 7 plus or minus 2, POD 14 plus or minus 3, and at discharge Short Physical Performance Battery (SPPB): preoperatively, POD 7 plus or minus 2, POD 14 plus or minus 3, and at discharge Handgrip strength: preoperatively, POD 7 plus or minus 2, POD 14 plus or minus 3, and at discharge ECOG Performance Status (ECOG-PS), G8 screening tool, and the Japanese version of the Cardiovascular Health Study (CHS) criteria: at study entry, at hospital admission, at discharge, POD 30 plus or minus 7, and POD 90 plus or minus 14 Time to first flatus and time to first bowel movement Psoas muscle area and mean psoas muscle CT attenuation at the L3 vertebral level Duration of Ninjin'yoeito administration, medication adherence, and treatment-related adverse events such as hypokalemia, hepatic dysfunction, and edema Medically ready for discharge (MRD)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Patients diagnosed with bladder cancer for whom radical cystectomy is indicated. 2. Patients planning to undergo robot-assisted radical cystectomy with urinary diversion at our institution. 3. Patients aged 18 years or older at the time of enrollment. 4. Patients who have provided written informed consent based on their own free will after receiving sufficient explanation of the study.
Exclude criteria	1. Patients who are expected to be unable to undergo standard oral intake or rehabilitation during the perioperative period. 2. Patients with incomplete medical records that prevent confirmation of postoperative treatment history or recurrence status (applicable to the retrospective cohort). 3. Patients who received non-insurance-covered treatments or investigational drugs for the treatment of urothelial carcinoma. 4. Patients deemed inappropriate for inclusion in the study by the principal investigator or sub-investigators.