Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-08 @ 9:50 PM
Study NCT ID:
NCT04142203
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2019-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of 23 Hour Surgery Model in a Tertiary Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'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'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 993}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events after 23 h surgery', 'timeFrame': 'two weeks after surgery', 'description': 'Adverse events after 23 h surgical procedure'}], 'primaryOutcomes': [{'measure': 'Amount of patients discharged from the hospital until 10 am at the first postoperative day', 'timeFrame': 'Postoperative day 1', 'description': 'The amount of patients discharged from hospital by the first postoperative day 10 am'}, {'measure': 'Pain intensity postoperatively', 'timeFrame': 'Postoperative day 1', 'description': 'Pain intensity after surgery for the first 24 hours'}, {'measure': 'Analgesic consumption postoperatively', 'timeFrame': 'Postoperative day 1', 'description': 'Amount of different analgesics consumed during the 24 h period postoperatively'}], 'secondaryOutcomes': [{'measure': '30 days readmission rate', 'timeFrame': 'one month after surgery', 'description': 'How many patients are admitted to hospital within 30 postoperative days'}, {'measure': '30 days reoperation rate', 'timeFrame': 'one month after surgery', 'description': 'How many patients are reoperated within 30 postoperative days'}, {'measure': 'Number of adverse events during 14 postoperative days', 'timeFrame': '14 days after surgery', 'description': 'Amount of adverse events after surgery within 14 postoperative days'}, {'measure': 'Contact to health care during 14 postoperative days', 'timeFrame': '14 days afte surgery', 'description': 'Number of contacts to health care within 14 postoperative days'}, {'measure': 'Patient satisfaction to care in 23 hours process', 'timeFrame': '14 days after surgery', 'description': 'Scale 0-7 (0= not satisfied, 7 =very satisfied), the higher score the better result'}, {'measure': 'Proportion of patients having pain postoperatively', 'timeFrame': 'Two weeks postoperatively', 'description': 'Amount of patients who had pain still two weeks after surgery'}, {'measure': 'Postoperative pain interference after 23 h surgery', 'timeFrame': 'two weeks postoperatively', 'description': 'Patient assessed pain interference in daily activities up to 2 weeks after surgery'}, {'measure': 'Analgesic use after 23 h surgery', 'timeFrame': 'Two weeks postoperatively', 'description': 'amount of patients using analgesics two weeks after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['23 h surgery', 'postoperative recovery', 'outcome', 'patient satisfaction', 'postoperative pain', 'analgesic', 'oxycodone', 'multimodal pain management', 'extended day surgery'], 'conditions': ['Ambulatory Surgery', 'Laparoscopy', 'Shoulder Impingement Syndrome', 'Ovarian Cysts', 'Cholecystolithiasis', 'Appendicitis', 'Gynecologic Surgical Procedures', 'Ambulatory Surgical Procedures', 'Neurosurgery']}, 'referencesModule': {'references': [{'pmid': '35974326', 'type': 'DERIVED', 'citation': 'Isokaanta S, Ruohoaho UM, Anttila M, Kokki H, Sintonen H, Toroi P, Kokki M. Resilience, pain, and health-related quality of life in gynecological patients undergoing surgery for benign and malignant conditions: a 12-month follow-up study. BMC Womens Health. 2022 Aug 16;22(1):345. doi: 10.1186/s12905-022-01923-7.'}, {'pmid': '35384504', 'type': 'DERIVED', 'citation': 'Ruohoaho UM, Aaltomaa S, Kokki H, Anttila M, Kokki M. Patient functional recovery after a 23-h surgery - a prospective, follow-up study. Langenbecks Arch Surg. 2022 Aug;407(5):2133-2142. doi: 10.1007/s00423-022-02502-y. Epub 2022 Apr 6.'}, {'pmid': '32109004', 'type': 'DERIVED', 'citation': 'Ruohoaho UM, Toroi P, Hirvonen J, Aaltomaa S, Kokki H, Kokki M. Implementation of a 23-h surgery model in a tertiary care hospital: a safe and feasible model with high patient satisfaction. BJS Open. 2020 Jun;4(3):391-399. doi: 10.1002/bjs5.50267. Epub 2020 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'Extended day surgery or 23 h surgery (23-hour surgery) is a surgical model where patients arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018 patients were recruited in the present prospective follow up cohort study. Patients were informed and they gave their informed consent. The patients were contacted two weeks after the study and details of their recovery were asked.', 'detailedDescription': 'Extended day surgery or 23 h surgery is a surgical model where patients arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018 patients were recruited in the present prospective follow up cohort study. Patients were informed and they gave their informed consent. The patients were contacted two weeks after the study and details of their recovery were asked. Satisfaction to the care in 23 h unit and surgical process, were asked. Amount of readmissions, reoperations, contacts to health care professionals and adverse events are recorded.\n\nDetailed information about intensity of pain, analgesic need and use in the hospital was recorded and pain interference in daily life for short term recovery period was asked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing 23 h surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* gave informed consent\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT04142203', 'acronym': 'Herko', 'briefTitle': 'Implementation of 23 Hour Surgery Model in a Tertiary Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': '23 Hour Surgical Model in a Tertiary Hospital: Evaluation From Patient and Organisational Perspective', 'orgStudyIdInfo': {'id': 'KUH507A030'}}, 'armsInterventionsModule': {'armGroups': [{'label': '23 h surgery', 'description': 'Adult patients who were treated in 23 h surgical unit', 'interventionNames': ['Other: 23 h surgery']}], 'interventions': [{'name': '23 h surgery', 'type': 'OTHER', 'description': 'Patients were treated in 23 surgical unit', 'armGroupLabels': ['23 h surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70029', 'city': 'Kuopio', 'state': 'Northern Savonia', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Ulla-Maija Ruohoaho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}