Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 3:00 PM
Study NCT ID:
NCT04963751
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2021-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized trial is proposed that will assess whether patient involvement in pre-operative counseling for ERAS improves post-surgical pain scores. Subject compliance will be assessed to ERAS-prescribed medications, and functionality (return to school). Each patient who is enrolled in the study will be assigned to 1) pre-operative counseling with their caregiver or 2) caregiver-only counseling.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain rating scores at post-op days 1 and 7', 'timeFrame': '1-7 days after surgery', 'description': 'Minimum value = 0, maximum value = 10. 0 = no pain at all, 10 = worst pain imaginable. A higher score on the rating scale indicates a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of participants who have returned to school at 7-days post-op', 'timeFrame': '7 days after surgery', 'description': 'Yes/no question asking whether the participants has returned to school'}, {'measure': 'Rate of medication adherence to ERAS-prescribed medications', 'timeFrame': '1-7 days after surgery', 'description': 'Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking.'}, {'measure': 'Rate of narcotic medication prescriptions', 'timeFrame': '1-7 days after surgery', 'description': 'Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gynecology', 'ERAS', 'Pediatrics'], 'conditions': ['Enhanced Recovery After Surgery', 'Gynecologic Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32061749/', 'label': 'Enhanced recovery after surgery in pediatric and adolescent gynecology: a pilot study. J Pediatr Adolesc Gynecol 2019; 32: 239'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/28545764/', 'label': 'Implementation of an enhanced recovery protocol in pediatric colorectal surgery. Journal of pediatric surgery, 53(4), 688-692.Kehlet H. (1997)'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/20116145/', 'label': 'The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/16496831/', 'label': 'The effect of pre-admission education on domiciliary recovery following laparoscopic cholecystectomy'}, {'url': 'https://europepmc.org/article/med/1960069', 'label': 'Effects of timing and reinforcement of preoperative education on knowledge and recovery of patients having coronary artery bypass graft surgery. Heart \\& lung: the journal of critical care, 20(6), 654-660.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31142954/', 'label': 'Preoperative patient preparation in enhanced recovery pathways'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/26620833/', 'label': 'Subanesthetic ketamine infusions for the treatment of children and adolescents with chronic pain: a longitudinal study.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/9175983/', 'label': 'Multimodal approach to control postoperative pathophysiology and rehabilitation. British journal of anaesthesia, 78(5), 606-617.'}]}, 'descriptionModule': {'briefSummary': "The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.", 'detailedDescription': "Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population.\n\nThe Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'genderBased': True, 'genderDescription': 'This study involves only Gynecologic surgeries.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9- 17 years of age\n* Patient is undergoing abdominal surgery and being managed under the ERAS protocol\n\nExclusion Criteria:\n\n* Developmental delay (IQ \\< 70) determined by documentation in medical record\n* Emergency or non-elective surgical cases\n* Patients who attend clinic appointments independently from their caregiver'}, 'identificationModule': {'nctId': 'NCT04963751', 'briefTitle': 'ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?', 'orgStudyIdInfo': {'id': '21-3205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pre-operative counseling with their caregiver', 'description': 'Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.', 'interventionNames': ['Other: Enhanced Recovery After Surgery (ERAS) Counseling to Patients']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'caregiver-only counseling.', 'description': 'Parents-only will attend a standard-of-care pre-operative teaching session.', 'interventionNames': ['Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver']}], 'interventions': [{'name': 'Enhanced Recovery After Surgery (ERAS) Counseling to Patients', 'type': 'OTHER', 'description': "In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.", 'armGroupLabels': ['pre-operative counseling with their caregiver']}, {'name': 'Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver', 'type': 'OTHER', 'description': "In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.", 'armGroupLabels': ['caregiver-only counseling.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Huguelet, MD', 'role': 'CONTACT', 'email': 'patricia.huguelet@cuanschutz.edu', 'phone': '720-777-2238'}], 'facility': "Pediatric and Gynecology Clinic at Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Patricia S Huguelet, MD', 'role': 'CONTACT', 'email': 'patricia.huguelet@cuanschutz.edu', 'phone': '(720)-777-2238'}, {'name': 'Jaime Laurin, MS', 'role': 'CONTACT', 'email': 'jaime.laurin@cuanschutz.edu', 'phone': '(720)-777-1375'}], 'overallOfficials': [{'name': 'Patricia Huguelet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}