Urologic Surgical ProceduresNCT03245242
Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
An observational study of Urologic Surgical Procedures and Urinary Bladder, Neurogenic, run by Washington University School of Medicine at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Urologic Surgical Procedures, Urinary Bladder, Neurogenic, Urinary Bladder Diseases
- What is being tested?
- Enhanced Recovery after Surgery and Historical usual surgical care
- How many people
- 85 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Apr 2017to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 72104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, 23221
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
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.
Read the 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.
- Being tested
- Enhanced Recovery after Surgery, Historical usual surgical care
- Keywords
- enhanced recovery after surgery, urologic reconstruction, pediatric urology, bladder augmentation, Mitrofanoff, Malone antegrade continence enema channel, appendicovesicostomy, ileovesicostomy, appendicocecostomy
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery after SurgeryOther
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 careOther
Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery | Prospectively enrolled group to receive standardized care under a set ERAS protocol/pathway. Receives: Other: Enhanced Recovery after Surgery | |
| 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. Receives: Other: Historical usual surgical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to ERAS protocol
Adherence to ERAS protocol items with # of items achieved (out of 20)
Measured: 3 years
Secondary outcomes (8)
Length of stay
Median primary inpatient hospital stay associated with surgery episode (# midnight)
Measured: 3 years
Re-admissions within 30 days
Median number of re-admissions to any hospital within 30 days of surgery episode per patient
Measured: 30 days
Re-operations within 90 days
Median number of unplanned re-operations within 90 days of surgery episode per patient
Measured: 90 days
Number of visits to the emergency room within 90 day period
Median number of visits to any emergency room within 90 days of surgery episode per patient
Measured: 90 days
Number of 30-day complications
Median number of 30-day complications by Clavien-Dindo classification per patient
Measured: 3 years
Number of 90-day complications
Median number of 90-day complications by Clavien-Dindo classification per patient
Measured: 3 years
Number of long-term complications within 1 year
Median number of long-term complications per patient
Measured: 1 year
Daily IV morphine equivalents
Mean daily IV morphine equivalents (mg/kg) usage during first 3 days after surgery
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Apr 2017
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urologic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Coplen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245242
- Sponsor's protocol ID
- 201703081
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2017
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore RP, Burjek NE, Brockel MA, Strine AC, Acks A, Boxley PJ, Chidambaran V, Vricella GJ, Chu DI, Sankaran-Raval M, Zee RS, Cladis FP, Chaudhry R, O'Reilly-Shah VN, Ahn JJ, Rove KO; PURSUE Study Group. Evaluating the role for regional analgesia in children with spina bifida: a retrospective observational study comparing the efficacy of regional versus systemic analgesia protocols following major urological surgery. Reg Anesth Pain Med. 2023 Jan;48(1):29-36. doi: 10.1136/rapm-2022-103823. Epub 2022 Sep 27.
PubMed 36167478Rove KO, Strine AC, Wilcox DT, Vricella GJ, Welch TP, VanderBrink B, Chu DI, Chaudhry R, Zee RS, Brockel MA; PURSUE Study group. Design and development of the Pediatric Urology Recovery After Surgery Endeavor (PURSUE) multicentre pilot and exploratory study. BMJ Open. 2020 Nov 23;10(11):e039035. doi: 10.1136/bmjopen-2020-039035.
PubMed 33234633
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT03245242
- Acronym / sponsor ID
- 201703081
- Keywords
- enhanced recovery after surgery, urologic reconstruction, pediatric urology, bladder augmentation, Mitrofanoff, Malone antegrade continence enema channel, appendicovesicostomy, ileovesicostomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery | – | Other: Enhanced Recovery after SurgeryProspectively enrolled group to receive standardized care under a set ERAS protocol/pathway. |
| Historical usual surgical care | – | Other: Historical usual surgical careRecent 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. |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery after SurgeryEnhanced 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. | Other | Enhanced Recovery After Surgery |
| Historical usual surgical careRecent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol. | Other | Historical usual surgical care |
Primary outcome
Adherence to ERAS protocol
Time frame: 3 years
Adherence to ERAS protocol items with # of items achieved (out of 20)
8 secondary outcomes
Length of stay
Time frame: 3 years
Re-admissions within 30 days
Time frame: 30 days
Re-operations within 90 days
Time frame: 90 days
Number of visits to the emergency room within 90 day period
Time frame: 90 days
Number of 30-day complications
Time frame: 3 years
Number of 90-day complications
Time frame: 3 years
Number of long-term complications within 1 year
Time frame: 1 year
Daily IV morphine equivalents
Time frame: 3 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 36167478Moore RP, Burjek NE, Brockel MA, Strine AC, Acks A, Boxley PJ, Chidambaran V, Vricella GJ, Chu DI, Sankaran-Raval M, Zee RS, Cladis FP, Chaudhry R, O'Reilly-Shah VN, Ahn JJ, Rove KO; PURSUE Study Group. Evaluating the role for regional analgesia in children with spina bifida: a retrospective observational study comparing the efficacy of regional versus systemic analgesia protocols following major urological surgery. Reg Anesth Pain Med. 2023 Jan;48(1):29-36. doi: 10.1136/rapm-2022-103823. Epub 2022 Sep 27.
- Derived from this study: PubMed 33234633Rove KO, Strine AC, Wilcox DT, Vricella GJ, Welch TP, VanderBrink B, Chu DI, Chaudhry R, Zee RS, Brockel MA; PURSUE Study group. Design and development of the Pediatric Urology Recovery After Surgery Endeavor (PURSUE) multicentre pilot and exploratory study. BMJ Open. 2020 Nov 23;10(11):e039035. doi: 10.1136/bmjopen-2020-039035.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Coplen, M.D. principal investigator
Washington University School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Surgical Procedures and Urinary Bladder, Neurogenic, run by Washington University School of Medicine at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to ERAS protocol (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245242, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.