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OpenTrials
Completed

NCT Number: NCT05905276

Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

This is a single-center, randomized-controlled trial to investigate the effectiveness of an ERAS protocol compared to usual care in patients with bladder cancer undergoing ambulatory TURBT. The ERAS protocol is comprised of pre, intra and postoperative components designed to optimize each phase of perioperative care.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with suspected or known bladder cancer
  • Age >= 18 years
  • Undergoing initial or repeat TURBT
  • Ambulatory TURBT with same day discharge home planned

Exclusion criteria

  • Undergoing a planned concomitant procedure
  • Inability to consent for themselves
  • Unable to complete telephone-based follow up after discharge home
  • Undergoing active treatment for muscle-invasive bladder cancer

Treatment and study plan

ERAS Protocol

Other

The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings.

Standard of care

Other

Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.

Primary outcomes

  1. Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    The QoR-15 score is a validated 15-item questionnaire that assesses quality of recovery in five dimensions: pain, physical comfort, functional autonomy, emotions, and psychological support. Each item is scored 0 to 10 with higher scores representing superior quality of recovery. The QoR-15 score is patient-reported outcome measure and has been extensively used to evaluate ERAS for both inpatient and ambulatory surgeries. It is a shorter and more patient-friendly version of the QoR-40 with equivalent psychometric properties.

Secondary outcomes

  1. Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8)

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    The UTI-SIQ-8 is a validated questionnaire of voiding symptom severity and bother, with higher scores representing worse symptoms (8-40).

  2. Change in quality of life for bladder cancer patients as assessed by the Bladder Utility Symptom Scale (BUSS)

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    Bladder Utility Symptom Scale - a validated 10-question instrument designed specifically for patients with bladder cancer, will be used to measure health-related quality of life (0-100), with higher scores representing higher quality of life.

  3. Change in Pain as assessed by Visual Analogue Scale

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    Dysuria, Suprapubic/Bladder, Urethral, Penis or Vulvar Pain Rated from 0 (No pain) to 10 (Unbearable pain)

  4. Change in patient satisfaction as assessed by patient self-report

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction).

  5. Change in degree of hematuria as assessed by patient self-report

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    None, Pink, Red, Red with Clots as self-reported by patients

  6. Change in incontinence

    Time frame: Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.

    Change in incontinence will be assessed by the average number of pads used per day

  7. Change in opioid consumption

    Time frame: Measured at enrollment through study completion, an average of 7 days.

    Change in opioid consumption (Morphine milligram equivalents) obtained from medical record

  8. Healthcare utilization

    Time frame: Measured at enrollment through study completion, an average of 30 days.

    Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually.

  9. Complications as assessed by Clavien-Dindo complications

    Time frame: Measured at enrollment through study completion, an average of 30 days.

    Surgical complications as classified by Clavien-Dindo category.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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