Bladder Cancer Clinical Trial
— PreActOfficial title:
Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)
NCT number | NCT06416319 |
Other study ID # | 2021-677 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 14, 2023 |
Est. completion date | March 14, 2026 |
A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.
Status | Recruiting |
Enrollment | 164 |
Est. completion date | March 14, 2026 |
Est. primary completion date | March 14, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer - Participants age = 18 years and capacity to consent - Mobile participant who is not dependent on a walking aid - The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure Exclusion Criteria: - Karnofsky performance status scale = 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities" - ASA Physical Status Classification: ASA > 3 (3: A patient with severe systemic disease) - ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.) - Emergency intervention |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Urology, University Medical Center Mannheim, University of Heidelberg | Mannheim | Baden-Württemberg |
Germany | Urologische Klinik München Planegg (UKMP) | München | Bayern |
Lead Sponsor | Collaborator |
---|---|
Universitätsmedizin Mannheim | Dr. Rolf M. Schwiete Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of steps per day | Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery. | Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down. | |
Secondary | Total number of steps | Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery. | Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down. | |
Secondary | Postoperative physical activity | The postoperative physical activity of the participants measured by the average number of steps per day and in total on postoperative days 1 to 3. Neither arm will receive a daily activity goal. However, the fitness trackers of the No Daily Activity Goal or Feedback arm are still covered. | Morning of postoperative day 4 at 7 PM | |
Secondary | Postoperative Complications | Postoperative complications measured by the Comprehensive Classification Index (CCI), on a scale from 0 (no complications) to 100 (death), (Slankamenac, Graf et al. 2013) and the Clavien-Dindo Classification (CDC), which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death (Clavien, Barkun et al. 2009):
CDC = 3a corresponding to a CCI = 26.2 defined as "severe complications" including CDC = 5 and CCI = 100 defined as "patient's death" and the total number of complications |
On postoperative day 30 and 90 | |
Secondary | Operating time | In minutes, incision - surgical incision closure | On the day of surgery | |
Secondary | Blod loss | In millilitres | On the day of surgery | |
Secondary | Required transfusion of blood products | Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma | On the day of surgery | |
Secondary | Feasibility of the planned urinary diversion | Yes or no | On the day of surgery | |
Secondary | Conversion rate | If the planned urinary diversion is not feasible | On the day of surgery | |
Secondary | Patient Reported Outcome Measures (PROMs) | SF-36: Health-related quality of life (Scale 0 - 100: The higher the score, the lower the disability. A score of 100 corresponds to no disability) | On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90 | |
Secondary | Length of hospital stay (LOS) | LOS measured by the number of days spent in the hospital after surgery until discharge | On the day of discharge which is on average 2 weeks after the surgery | |
Secondary | Readmission rate | Readmissions due to a complication of the radical cystectomy | On postoperative day 90 if occured | |
Secondary | Reoperation rate | Reoperation due to a complication of the radical cystectomy | On postoperative day 90 if occured | |
Secondary | Length of stay in the intensive care unit (ICU) | Days spent in the ICU after surgery | On postoperative day 90 if occured |
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