We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03245242
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS) protocol in children and young adults undergoing urologic reconstructive surgery. The investigators plan to collect data on speed of recovery (how quickly pain improves, length of time in the hospital, and the need for additional pain control) on patients who receive care under the ERAS protocol and compare it to historical controls.

Condition or disease Intervention/treatment
Urologic Surgical Procedures Urinary Bladder, Neurogenic Urinary Bladder Diseases Other: Enhanced Recovery after Surgery Other: Historical usual surgical care

Detailed Description:

The purpose of this project is to evaluate Enhanced Recovery After Surgery (ERAS) in the pediatric setting for participants undergoing intraabdominal urologic reconstruction procedures. ERAS practices are being implemented in the department independent of research and this project will allow the investigators to review these practices.

Providers, participants, and family members will complete pre- and post- surgery questionnaires. These questionnaires are geared to collect demographic information about the participant and how the surgery affects their life situation. The providers will answer questions regarding their experience with ERAS.

Evidence-based ERAS principles and procedures are compulsory components of this project. These will be documented in the medical record and are considered standard of care practice as part of perioperative patient care.

Data collected from the medical record for each participant will aid in evaluating if adherence to the ERAS protocol is achieved.


Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Diseases
U.S. FDA Resources

Group/Cohort Intervention/treatment
Enhanced Recovery After Surgery
Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway.
Other: Enhanced Recovery after Surgery
Enhanced Recovery After Surgery (ERAS) protocol is a multi-disciplinary program that aims to standardize care processes around the pre-, intra-, and post-operative care setting. This group will prospectively receive care under a pre-defined protocol.
Historical usual surgical care
Recent historical patients (5 years prior to start of ERAS) that will be propensity-matched to ERAS patients to be used as controls for comparison of outcomes.
Other: Historical usual surgical care
Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.



Primary Outcome Measures :
  1. Adherence to ERAS protocol [ Time Frame: 3 years ]
    Adherence to ERAS protocol items with # of items achieved (out of 20)


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 3 years ]
    Median primary inpatient hospital stay associated with surgery episode (# midnight)

  2. Re-admissions within 30 days [ Time Frame: 30 days ]
    Median number of re-admissions to any hospital within 30 days of surgery episode per patient

  3. Re-operations within 90 days [ Time Frame: 90 days ]
    Median number of unplanned re-operations within 90 days of surgery episode per patient

  4. Number of visits to the emergency room within 90 day period [ Time Frame: 90 days ]
    Median number of visits to any emergency room within 90 days of surgery episode per patient

  5. Number of 30-day complications [ Time Frame: 3 years ]
    Median number of 30-day complications by Clavien-Dindo classification per patient

  6. Number of 90-day complications [ Time Frame: 3 years ]
    Median number of 90-day complications by Clavien-Dindo classification per patient

  7. Number of long-term complications within 1 year [ Time Frame: 1 year ]
    Median number of long-term complications per patient

  8. Daily IV morphine equivalents [ Time Frame: 3 days after surgery ]
    Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

There are 2 populations:

  1. ERAS patients: a. ages 4-17 and, b. transitional young adult 18-25
  2. Historical patients: a. ages 4-17 and, b. transitional young adult 18-25
Criteria

Inclusion criteria:

  • Age greater than or equal to 4 or <26 years at time of surgery
  • Undergoing urologic reconstructive surgery that includes primary bowel anastomosis (i.e., creation of continent ileovesicostomy [Monti], sigmoid Monti channel, enterocystoplasty)
  • Undergoing urologic reconstructive surgery that includes possible bowel anastomosis (planned creation of continent appendicovesicostomy [Mitrofanoff] with inability to use appendix at time of surgery and creation of alternative channel requiring primary bowel anastomosis)

Exclusion criteria:

• Clinically constipated (defined as Bristol 1 or 2 stools more than once per week, bowel movement interval > every other day [e.g. only has bowel movement every 3 days, or palpable stool in > 50% of colon on physical preoperative exam)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245242


Contacts
Contact: Gino Vricella, M.D. 314-454-6034 vricellag@wustl.edu
Contact: Kyle Rove, M.D. 314-454-6034 rovek@wustl.edu

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sheryl Holbrook    720-777-2678    Sheryl.Holbrook@childrenscolorado.org   
Contact: Duncan Wilcox, MD    720-777-1234    duncan.wilcox@childrenscolorado.org   
Principal Investigator: Duncan Wilcox, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kyle Rove, M.D.    314-454-6034    rovek@wustl.edu   
Contact: Gino Vricella, M.D.    314-454-6034    vricellag@wustl.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Marion E Schulte    513-803-9093    marion.schulte@cchmc.org   
Contact: Andrew Strine, MD    (513) 636-4975    andrew.strine@cchmc.org   
Sub-Investigator: Andrew Strine, MD         
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jennifer Clayton    412-692-7949    Jennifer.clayton2@chp.edu   
Contact: Rajeev Chaudhry, MD    412-692-7466    rajeev.chaudhry@chp.edu   
Sub-Investigator: Rajeev Chaudhry, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kyle Rove, M.D. Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03245242     History of Changes
Other Study ID Numbers: 201703081
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
enhanced recovery after surgery
urologic reconstruction
pediatric urology
bladder augmentation
Mitrofanoff
Malone antegrade continence enema channel
appendicovesicostomy
ileovesicostomy
appendicocecostomy

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urinary Bladder, Neurogenic
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms