- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04142203
Implementation of 23 Hour Surgery Model in a Tertiary Hospital (Herko)
23 Hour Surgical Model in a Tertiary Hospital: Evaluation From Patient and Organisational Perspective
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Northern Savo
-
Kuopio, Northern Savo, Finland, 70029
- Kuopio University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult
- gave informed consent
Exclusion Criteria:
- no informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
23 h surgery
Adult patients who were treated in 23 h surgical unit
|
Patients were treated in 23 surgical unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of patients discharged from the hospital until 10 am at the first postoperative day
Time Frame: Postoperative day 1
|
The amount of patients discharged from hospital by the first postoperative day 10 am
|
Postoperative day 1
|
Pain intensity postoperatively
Time Frame: Postoperative day 1
|
Pain intensity after surgery for the first 24 hours
|
Postoperative day 1
|
Analgesic consumption postoperatively
Time Frame: Postoperative day 1
|
Amount of different analgesics consumed during the 24 h period postoperatively
|
Postoperative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 days readmission rate
Time Frame: one month after surgery
|
How many patients are admitted to hospital within 30 postoperative days
|
one month after surgery
|
30 days reoperation rate
Time Frame: one month after surgery
|
How many patients are reoperated within 30 postoperative days
|
one month after surgery
|
Number of adverse events during 14 postoperative days
Time Frame: 14 days after surgery
|
Amount of adverse events after surgery within 14 postoperative days
|
14 days after surgery
|
Contact to health care during 14 postoperative days
Time Frame: 14 days afte surgery
|
Number of contacts to health care within 14 postoperative days
|
14 days afte surgery
|
Patient satisfaction to care in 23 hours process
Time Frame: 14 days after surgery
|
Scale 0-7 (0= not satisfied, 7 =very satisfied), the higher score the better result
|
14 days after surgery
|
Proportion of patients having pain postoperatively
Time Frame: Two weeks postoperatively
|
Amount of patients who had pain still two weeks after surgery
|
Two weeks postoperatively
|
Postoperative pain interference after 23 h surgery
Time Frame: two weeks postoperatively
|
Patient assessed pain interference in daily activities up to 2 weeks after surgery
|
two weeks postoperatively
|
Analgesic use after 23 h surgery
Time Frame: Two weeks postoperatively
|
amount of patients using analgesics two weeks after surgery
|
Two weeks postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events after 23 h surgery
Time Frame: two weeks after surgery
|
Adverse events after 23 h surgical procedure
|
two weeks after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulla-Maija Ruohoaho, MD, Kuopio University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Neoplasms
- Wounds and Injuries
- Endocrine System Diseases
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Gastroenteritis
- Shoulder Injuries
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Gallbladder Diseases
- Biliary Tract Diseases
- Cecal Diseases
- Intraabdominal Infections
- Calculi
- Shoulder Impingement Syndrome
- Appendicitis
- Gallstones
- Cholelithiasis
- Cholecystolithiasis
- Ovarian Cysts
Other Study ID Numbers
- KUH507A030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cysts
-
Ann & Robert H Lurie Children's Hospital of ChicagoUnknownCystectomy | Benign Cysts Ovarian | Torsion | Malignant Cysts OvarianUnited States
-
Sorlandet Hospital HFUniversity of SurreyCompleted
-
Shandong Provincial HospitalShandong UniversityCompleted
-
Ain Shams UniversityNot yet recruitingOvarian Cyst Benign
-
Seoul National University HospitalCompletedOvarian Cyst BenignKorea, Republic of
-
Peking University Third HospitalRecruitingPolycystic Ovary SyndromeChina
-
University Hospital, MontpellierBaxter Healthcare CorporationNot yet recruitingBenign Ovarian Cyst | CystectomyFrance
-
Ahmed MagedCompletedPolycystic Ovarian Syndrome
-
University of AarhusCompletedPolycystic Ovarian DiseaseDenmark
-
Assiut UniversityNot yet recruiting
Clinical Trials on 23 h surgery
-
The Ludwig Boltzmann Institute of Retinology and...CompletedPostoperative Complications | Diabetic Retinopathy | Macular Edema | Vitreous HemorrhageAustria
-
Alcon ResearchCompletedVitreoretinal DiseaseUnited States
-
Allysta PharmaceuticalCompleted
-
Sinovac Biotech Co., LtdCompletedPneumococcal InfectionsChina
-
Fable Biyoteknoloji San ve Tic A.SRecruiting
-
Huashan HospitalRecruitingNeurodegenerative Diseases | Alzheimer Disease | Positron Emission TomographyChina
-
Elizabeth K RhodusEmory University; National Institute on Aging (NIA)CompletedMental Disorders | Brain Diseases | Central Nervous System Diseases | Nervous System Diseases | Neurocognitive Disorders | Neurodegenerative Diseases | Dementia | Alzheimer Disease | TauopathiesUnited States
-
Grupo Español de Tratamiento de Tumores de Cabeza...CompletedHead and Neck CancerSpain
-
Alanya Alaaddin Keykubat UniversityCompletedChronic Low-back PainTurkey
-
Statens Serum InstitutCompleted