Ambulatory SurgeryHerkoNCT04142203
Implementation of 23 Hour Surgery Model in a Tertiary Hospital
An observational study of Ambulatory Surgery and Laparoscopy, run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ambulatory Surgery, Laparoscopy, Shoulder Impingement Syndrome
- What is being tested?
- 23 h surgery
- How many people
- 993 participants
- Where
- 1 siteFinland
- Study dates
- 16 May 2017to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing 23 h surgery
Who may be able to join
- adult
- gave informed consent
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 23 Hour Surgical Model in a Tertiary Hospital: Evaluation From Patient and Organisational Perspective
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.
Read the 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.
- Conditions
- Ambulatory Surgery, Laparoscopy, Shoulder Impingement Syndrome, Ovarian Cysts, Cholecystolithiasis, Appendicitis
- Being tested
- 23 h surgery
- Keywords
- 23 h surgery, postoperative recovery, outcome, patient satisfaction, postoperative pain, analgesic, oxycodone, multimodal pain management, extended day surgery
- Medical subject headings
- Shoulder Impingement Syndrome, Ovarian Cysts, Cholecystolithiasis, Appendicitis, Patient Satisfaction, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23 h surgeryOther
Patients were treated in 23 surgical unit
| Study group | Role | What they receive |
|---|---|---|
| 23 h surgery | Adult patients who were treated in 23 h surgical unit Receives: Other: 23 h surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day 1
Pain intensity postoperatively
Pain intensity after surgery for the first 24 hours
Measured: Postoperative day 1
Analgesic consumption postoperatively
Amount of different analgesics consumed during the 24 h period postoperatively
Measured: Postoperative day 1
Secondary outcomes (8)
30 days readmission rate
How many patients are admitted to hospital within 30 postoperative days
Measured: one month after surgery
30 days reoperation rate
How many patients are reoperated within 30 postoperative days
Measured: one month after surgery
Number of adverse events during 14 postoperative days
Amount of adverse events after surgery within 14 postoperative days
Measured: 14 days after surgery
Contact to health care during 14 postoperative days
Number of contacts to health care within 14 postoperative days
Measured: 14 days afte surgery
Patient satisfaction to care in 23 hours process
Scale 0-7 (0= not satisfied, 7 =very satisfied), the higher score the better result
Measured: 14 days after surgery
Proportion of patients having pain postoperatively
Amount of patients who had pain still two weeks after surgery
Measured: Two weeks postoperatively
Postoperative pain interference after 23 h surgery
Patient assessed pain interference in daily activities up to 2 weeks after surgery
Measured: two weeks postoperatively
Analgesic use after 23 h surgery
amount of patients using analgesics two weeks after surgery
Measured: Two weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start16 May 2017
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ambulatory SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 993 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulla-Maija Ruohoaho, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142203
- Sponsor's protocol ID
- KUH507A030
- Acronym
- Herko
- Status last verified
- Feb 2022
- First submitted
- 17 Oct 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35974326Ruohoaho 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.
PubMed 35384504Ruohoaho 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.
PubMed 32109004
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 23 Hour Surgical Model in a Tertiary Hospital: Evaluation From Patient and Organisational Perspective
- ClinicalTrials.gov ID
- NCT04142203
- Acronym / sponsor ID
- Herko / KUH507A030
- Conditions
- Ambulatory Surgery, Laparoscopy, Shoulder Impingement Syndrome, Ovarian Cysts, Cholecystolithiasis, Appendicitis
- Keywords
- 23 h surgery, postoperative recovery, outcome, patient satisfaction, postoperative pain, analgesic, oxycodone, multimodal pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 993 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 23 h surgery | – | Other: 23 h surgeryAdult patients who were treated in 23 h surgical unit |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing 23 h surgery
Key inclusion criteria (2 listed)
- adult
- gave informed consent
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 23 h surgeryPatients were treated in 23 surgical unit | Other | 23 h surgery |
Primary outcome
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
Pain intensity postoperatively
Time frame: Postoperative day 1
Pain intensity after surgery for the first 24 hours
Analgesic consumption postoperatively
Time frame: Postoperative day 1
Amount of different analgesics consumed during the 24 h period postoperatively
8 secondary outcomes
30 days readmission rate
Time frame: one month after surgery
30 days reoperation rate
Time frame: one month after surgery
Number of adverse events during 14 postoperative days
Time frame: 14 days after surgery
Contact to health care during 14 postoperative days
Time frame: 14 days afte surgery
Patient satisfaction to care in 23 hours process
Time frame: 14 days after surgery
Proportion of patients having pain postoperatively
Time frame: Two weeks postoperatively
Postoperative pain interference after 23 h surgery
Time frame: two weeks postoperatively
Analgesic use after 23 h surgery
Time frame: Two weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 35974326Isokaanta 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.
- Derived from this study: PubMed 35384504Ruohoaho 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.
- Derived from this study: PubMed 32109004Ruohoaho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla-Maija Ruohoaho, MD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Surgery and Laparoscopy, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of patients discharged from the hospital until 10 am at the first postoperative day (time frame: Postoperative day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142203, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.