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NCT Number: NCT03245242

Pediatric Urology Recovery After Surgery Endeavor (PURSUE)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

4 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Enhanced recovery after surgery

Other

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

Other

Recent historical controls will have received care under "usual care" that existed prior to implementation of an enhanced recovery protocol.

Primary outcomes

  1. Adherence to ERAS protocol

    Time frame: 3 years

    Adherence to ERAS protocol items with # of items achieved (out of 20)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Multicenter Pilot and Exploration Study of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Urologic Reconstructive Surgery

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2017
Registry last updated
Dec 26, 2025

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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