CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 597 enrolled / 597 target
Drug / intervention
Perioperative surgical careprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04060303
NCT04060303Phase 3CompletedHigh Momentum (8.3/mo)Completion was 19mo ago

Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery

Northwestern University·interventional·Posted Aug 19, 2019·Updated Jun 23, 2026

In Brief

A Phase 3 clinical trial evaluating Perioperative surgical care for Inflammatory Bowel Disease and 2 related conditions. Completed, enrolled 597 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are lacking. The Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery, which has the short title "ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US)," study is a multicenter, pragmatic, prospective study, using a stepped wedge cluster randomized controlled trial design. The study is designed to test the adoption, effectiveness, and generalizability of a newly developed, 21-element ERP for children undergoing elective gastrointestinal surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 19, 2019
Enrollment StartJul 1, 2020
Primary CompletionNov 6, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.9 years ago

Arms & Interventions

ENRICH-US Implementation- earlyactive_comparator

Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator. Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.

Procedure: Perioperative surgical care
ENRICH-US Implementation- midactive_comparator

Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator. Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.

Procedure: Perioperative surgical care
ENRICH-US Implementation- lateactive_comparator

Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator. Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.

Procedure: Perioperative surgical care

Interventions

Perioperative surgical careprocedure

The ENRICH-US Protocol includes perioperative counseling and education, maintaining euvolumia through limited perioperative fasting and limited intraoperative fluid resuscitation, early enteral intake and mobilization, limited use of opioids, and non-routine use of surgical drains and tubes. Elements span the pre-, intra-, and post-operative experience for patients and involve care coordination among surgery, anesthesia, and nursing providers. Though individually simple, the concomitant implementation of the combined elements results in a markedly improved patient care experience that mitigates the physiologic stress of surgery and hastens recovery.