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Enhanced Recovery Protocol for Pediatric Gastrointestinal Surgery (ENRICH-US Trial)

Phase 3

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric patients ages 10-18

Undergoing elective (non-emergency) gastrointestinal/colorectal surgical procedures

Must not have

Children undergoing emergent/urgent gastrointestinal/colorectal surgical procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after surgery

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is designed to test the effectiveness of a new, 21-element protocol for children undergoing elective gastrointestinal surgery.

Who is the study for?

This trial is for children aged 10-18 with conditions like Crohn's Disease or Ulcerative Colitis, who are scheduled for elective gastrointestinal surgery. It's not open to those needing urgent surgeries or families unable to understand English or Spanish.

What is being tested?

The ENRICH-US study tests a new perioperative care protocol designed to improve recovery after elective gastrointestinal surgery in kids. This multicenter trial compares traditional care with the new 21-element Enhanced Recovery Protocol.

What are the potential side effects?

Since this trial focuses on surgical care procedures rather than medication, side effects may include typical post-surgical risks such as pain, infection at the incision site, and delayed recovery times.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 18 years old.

Select...

I am scheduled for a planned surgery on my digestive system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child is having an urgent surgery for a digestive system issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (prior to surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (prior to surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of stay (LOS)

Secondary study objectives

Hospital readmission

Immediate post-operative Quality of Life assessment

Intraoperative fluid use

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Group I: ENRICH-US Implementation- midActive Control1 Intervention

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.

Group II: ENRICH-US Implementation- lateActive Control1 Intervention

Group III: ENRICH-US Implementation- earlyActive Control1 Intervention

0 / 3Eligibility criteria met