NCT04142203

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
993

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

April 12, 2022

Status Verified

February 1, 2022

Enrollment Period

4 years

First QC Date

October 17, 2019

Last Update Submit

April 5, 2022

Conditions

Keywords

23 h surgerypostoperative recoveryoutcomepatient satisfactionpostoperative painanalgesicoxycodonemultimodal pain managementextended day surgery

Outcome Measures

Primary Outcomes (3)

  • 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

  • Pain intensity postoperatively

    Pain intensity after surgery for the first 24 hours

    Postoperative day 1

  • Analgesic consumption postoperatively

    Amount of different analgesics consumed during the 24 h period postoperatively

    Postoperative day 1

Secondary Outcomes (8)

  • 30 days readmission rate

    one month after surgery

  • 30 days reoperation rate

    one month after surgery

  • Number of adverse events during 14 postoperative days

    14 days after surgery

  • Contact to health care during 14 postoperative days

    14 days afte surgery

  • Patient satisfaction to care in 23 hours process

    14 days after surgery

  • +3 more secondary outcomes

Other Outcomes (1)

  • Adverse events after 23 h surgery

    two weeks after surgery

Study Arms (1)

23 h surgery

Adult patients who were treated in 23 h surgical unit

Other: 23 h surgery

Interventions

Patients were treated in 23 surgical unit

23 h surgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults undergoing 23 h surgery

You may qualify if:

  • adult
  • gave informed consent

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Shoulder Impingement SyndromeOvarian CystsCholecystolithiasisAppendicitisPatient SatisfactionPain, Postoperative

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesCholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ulla-Maija Ruohoaho, MD

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 29, 2019

Study Start

May 16, 2017

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

April 12, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations