Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05962320
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2023-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D062885', 'term': 'Urinary Catheters'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-06-18', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative length of hospital stay', 'timeFrame': 'From the end of surgery until hospital discharge, up to 10 days', 'description': 'The postoperative length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'up to 30 days after discharge', 'description': 'Postoperative minor and major complications will be recorded.'}, {'measure': 'Readmission', 'timeFrame': 'up to 30 days after discharge', 'description': 'Readmission to the hospital will be recorded in hours.'}, {'measure': 'Postoperative pain', 'timeFrame': 'Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours', 'description': 'Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome'}, {'measure': 'Postoperative fear', 'timeFrame': 'Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours', 'description': "Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe fear, worse outcome."}, {'measure': 'Postoperative anxiety', 'timeFrame': 'Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours', 'description': "Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe anxiety, worse outcome."}, {'measure': 'Postoperative nausea-vomiting', 'timeFrame': 'Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours', 'description': 'Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe nause, worse outcome'}, {'measure': 'Postoperative thirst', 'timeFrame': 'up to the first oral intake, an average 2 days', 'description': 'Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.'}, {'measure': 'Time of first mobilization', 'timeFrame': 'up to the first mobilization, an average 12 hours', 'description': 'The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.'}, {'measure': 'Time of first defecation', 'timeFrame': 'up to the first defecation, an average 3 days', 'description': 'The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Appendectomy', 'Nurse', 'Child', 'Pain', 'Length of Stay', 'Anxiety', 'Fear', 'Vomiting'], 'conditions': ['ERAS', 'Surgery', 'Appendicitis']}, 'descriptionModule': {'briefSummary': 'Acute appendicitis is the most common abdominal emergency with more than 15 million cases reported worldwide. Although appendectomy is considered a safe surgical procedure, the incidence of complications is up to 10%. The Enhanced Recovery After Surgery (ERAS) has developed guidelines to improve postoperative patient outcomes. The protocol, which consists of more than 20 interventions in the preoperative, intraoperative and postoperative periods, shows that early discharge can be possible with multidisciplinary care given to surgical patients without risking patient safety.', 'detailedDescription': 'Appendicitis is a common clinical condition and often requires emergency treatment. Although appendectomy is a safe surgical procedure, there is a risk of complications. Pain is common, especially in the postoperative period, and the lack of care management leads to delayed mobilization and oral intake, delayed recovery and prolonged length of hospital stay. However, pain, nausea-vomiting, thirst, fear and stress could be managed with perioperative care. In addition, it is reported that the care provided based on the ERAS protocol shortens the length of hospital stay. In this respect, the aim of this study was to investigate the effect of ERAS protocol-based care on the length of hospital stay of children who were planned to undergo appendectomy. Postoperative pain level, stress and fear level, time to first mobilization, flatulence, defecation and oral intake, nausea, thirst were the secondary outcomes of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥6 years and ≤17 years, girls or boys\n* Underwent appendectomy\n* Written informed consent or requirements of local/national ethical committee\n\nExclusion Criteria:\n\n* ASA (American Society of Anesthesiologists, ASA) score of ≥ 3\n* Any comorbidity/contraindication that may prevent mobilization and oral feeding\n\nThe withdrawal criteria:\n\n* During the surgery, the surgeon classified appendicitis as grade 0 (no appendicitis) or grade IIIB and above,\n* during the postoperative period need for intensive care hospitalization patients in the control or the mERAS protocol group were staying in the same room,\n* contraindications to the application of any intervention in the intervention group and/or the primary physician not approving the application of the intervention,\n* the compliance rate of the interventions determined in the modified ERAS protocol being below 80%,\n* the development of any other comorbidity (urinary calculi, intussusception, etc.),\n* the change in the type of surgery during the operation, conversion from laparoscopic to open appendectomy.'}, 'identificationModule': {'nctId': 'NCT05962320', 'briefTitle': 'Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KaradenizTU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mERAS Group', 'description': '* Education and counselling of patients and their parents\n* Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible\n* Stimulation of intestinal motility in the postoperative period\n* Initiation of oral intake in the early postoperative period\n* Early removal of the patient by reducing postoperative IV fluid infusion\n* Initiation of early mobilization of the patient in the postoperative period\n* Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions\n* Non-pharmacological interventions in management nausea and vomiting\n* Management of thirsty through non-pharmacological interventions\n* Management of fear and anxiety through non-pharmacological interventions', 'interventionNames': ['Other: Education and counselling', 'Other: Avoiding the use of nasogastric catheters, drains and urinary catheters', 'Other: Stimulation of intestinal motility in the postoperative period', 'Other: Initiation of oral intake in the early postoperative period', 'Other: Early removal of the patient by reducing postoperative IV fluid infusion', 'Other: Initiation of early mobilization of the patient in the postoperative period', 'Other: Reducing opioid use and ensuring pain management', 'Other: Implement nausea and vomiting prophylaxis', 'Other: Management of thirsty', 'Other: Management of fear and stress']}, {'type': 'NO_INTERVENTION', 'label': 'Standart Care Group', 'description': 'Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.'}], 'interventions': [{'name': 'Education and counselling', 'type': 'OTHER', 'description': 'Education and counselling of patients and their parents', 'armGroupLabels': ['mERAS Group']}, {'name': 'Avoiding the use of nasogastric catheters, drains and urinary catheters', 'type': 'OTHER', 'description': 'Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible', 'armGroupLabels': ['mERAS Group']}, {'name': 'Stimulation of intestinal motility in the postoperative period', 'type': 'OTHER', 'description': 'Stimulation of intestinal motility in the postoperative period', 'armGroupLabels': ['mERAS Group']}, {'name': 'Initiation of oral intake in the early postoperative period', 'type': 'OTHER', 'description': 'Initiation of oral intake in the early postoperative period', 'armGroupLabels': ['mERAS Group']}, {'name': 'Early removal of the patient by reducing postoperative IV fluid infusion', 'type': 'OTHER', 'description': 'Early removal of the patient by reducing postoperative IV fluid infusion', 'armGroupLabels': ['mERAS Group']}, {'name': 'Initiation of early mobilization of the patient in the postoperative period', 'type': 'OTHER', 'description': 'Initiation of early mobilization of the patient in the postoperative period', 'armGroupLabels': ['mERAS Group']}, {'name': 'Reducing opioid use and ensuring pain management', 'type': 'OTHER', 'description': 'Reducing opioid use and ensuring pain management', 'armGroupLabels': ['mERAS Group']}, {'name': 'Implement nausea and vomiting prophylaxis', 'type': 'OTHER', 'description': 'Implement nausea and vomiting prophylaxis', 'armGroupLabels': ['mERAS Group']}, {'name': 'Management of thirsty', 'type': 'OTHER', 'description': 'Management of thirsty', 'armGroupLabels': ['mERAS Group']}, {'name': 'Management of fear and stress', 'type': 'OTHER', 'description': 'Use of recommended non-pharmacological interventions in the management of fear and stress', 'armGroupLabels': ['mERAS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61080', 'city': 'Trabzon', 'state': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Buket MERAL, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz Technical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The individual participant data, with identifying information concealed, forming the basis of the results reported in this article, will be made available upon reasonable request to the corresponding author 6-12 months after publication of the article. Researchers should contact the corresponding author to request access to the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research asistant - MSc', 'investigatorFullName': 'Buket MERAL', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}