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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04142203
Other study ID # KUH507A030
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 16, 2017
Est. completion date May 30, 2021

Study information

Verified date February 2022
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 993
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - adult - gave informed consent Exclusion Criteria: - no informed consent

Study Design


Intervention

Other:
23 h surgery
Patients were treated in 23 surgical unit

Locations

Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (1)

Lead Sponsor Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events after 23 h surgery Adverse events after 23 h surgical procedure two weeks after surgery
Primary Amount of patients discharged from the hospital until 10 am at the first postoperative day The amount of patients discharged from hospital by the first postoperative day 10 am Postoperative day 1
Primary Pain intensity postoperatively Pain intensity after surgery for the first 24 hours Postoperative day 1
Primary Analgesic consumption postoperatively Amount of different analgesics consumed during the 24 h period postoperatively Postoperative day 1
Secondary 30 days readmission rate How many patients are admitted to hospital within 30 postoperative days one month after surgery
Secondary 30 days reoperation rate How many patients are reoperated within 30 postoperative days one month after surgery
Secondary Number of adverse events during 14 postoperative days Amount of adverse events after surgery within 14 postoperative days 14 days after surgery
Secondary Contact to health care during 14 postoperative days Number of contacts to health care within 14 postoperative days 14 days afte surgery
Secondary Patient satisfaction to care in 23 hours process Scale 0-7 (0= not satisfied, 7 =very satisfied), the higher score the better result 14 days after surgery
Secondary Proportion of patients having pain postoperatively Amount of patients who had pain still two weeks after surgery Two weeks postoperatively
Secondary Postoperative pain interference after 23 h surgery Patient assessed pain interference in daily activities up to 2 weeks after surgery two weeks postoperatively
Secondary Analgesic use after 23 h surgery amount of patients using analgesics two weeks after surgery Two weeks postoperatively
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