ENhanced Recovery in CHildren Undergoing Surgery (ENRICH-US)
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ClinicalTrials.gov Identifier: NCT04060303 |
Recruitment Status :
Recruiting
First Posted : August 19, 2019
Last Update Posted : May 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis | Procedure: Perioperative surgical care | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1260 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | A stepped-wedge, cluster-randomized study design will be used in which the participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period. |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery |
Actual Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | January 1, 2024 |
Estimated Study Completion Date : | August 31, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ENRICH-US Implementation- early
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
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. |
Active Comparator: ENRICH-US Implementation- mid
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
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. |
Active Comparator: ENRICH-US Implementation- late
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
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. |
- Length of stay (LOS) [ Time Frame: Up to 30 days after surgery ]Measured in days from surgery to discharge.
- Intraoperative fluid use [ Time Frame: Intraoperative ]intravenous fluids given during surgery (measured in mL/kg)
- Surgical Complications [ Time Frame: Up to 30 days after surgery ]wound infections, pneumonia, urinary tract infections within 30 days of surgery
- Hospital readmission [ Time Frame: Up to 30 days after surgery ]Post discharge hospital readmission within 30 days of surgery.
- Intraoperative opioid use [ Time Frame: Intraoperative ]opioids used during surgery measured in morphine equivalents mg/kg
- Postoperative opioid use [ Time Frame: Up to 30 days after surgery ]opioids from surgery until discharge measured in morphine equivalents mg/kg
- Post-discharge opioid prescribed [ Time Frame: Up to 30 days after surgery ]Opioids prescribed at discharge measured in morphine equivalents mg/kg
- Time to regular diet [ Time Frame: Up to 30 days after surgery ]Time from intestinal surgery to resumption of regular diet (measured in days)
- Preoperative Quality of Life assessment [ Time Frame: Baseline (prior to surgery) ]Health Related Quality of Life assessment using Pediatric Quality of Life (PedsQL) inventory. Total scores spanning all domains (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Scores total to 100. Scores >90 considered normal. This measurement will be collected prior to surgery.
- Immediate post-operative Quality of Life assessment [ Time Frame: 48 hours after surgery ]Health Related Quality of Life assessments: Pediatric Quality of Life (PedsQL) inventory. Total scores spanning all domains (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Scores total to 100. Scores >90 considered normal. This measurement will be collected within 48 hours after surgery
- Long-term post-operative Quality of Life assessment [ Time Frame: 2 weeks after surgery ]Health Related Quality of Life assessments: Pediatric Quality of Life (PedsQL) inventory. Total scores spanning all domains (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Scores total to 100. Scores >90 considered normal. This measurement will be collected 2 weeks after surgery.

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Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Pediatric patients ages 10-18
- Undergoing elective (non-emergency) gastrointestinal/colorectal surgical procedures
Exclusion Criteria:
- Children undergoing emergent/urgent gastrointestinal/colorectal surgical procedures
- Patients/families who cannot read and write English or Spanish

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): NCT04060303
Contact: Mehul Raval, MD, MS | 3122274210 | mraval@luriechildrens.org |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Mehul Raval, MD, MS |
Responsible Party: | Mehul Raval, Associate Professor of Surgery and Pediatrics, Northwestern University |
ClinicalTrials.gov Identifier: | NCT04060303 |
Other Study ID Numbers: |
Pro00039201 R01HD099344 ( U.S. NIH Grant/Contract ) |
First Posted: | August 19, 2019 Key Record Dates |
Last Update Posted: | May 5, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | All data collected during the study will be made available such that further advancement of ERP principles will be made possible by building upon these data. In addition to the peer-reviewed publication of study results and the dissemination of findings through publicly available websites, blogs, and newsletters, the PI and Biostatistics Director will create a patient-deidentified data set that will be made publicly available to researchers. We have included a request for funds to curate this dataset for public use. It will include clinical data and outcomes collected through REDCap for the complete ENRICH-US study, as well as, raw data for the PedsQL health-related quality of life surveys. All data will be fully de-identified. A copy of the study protocol, data definition dictionary, and public use file with instructions will also be generated for ease of use. Data will be made available in a format that will easily be used in mainstream software analysis packages (e.g., ASCII, SAS). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pediatric Surgery Implementation Quality Improvement Enhanced Recovery Protocols Gastrointestinal Surgery |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |