- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06809036
Mobilisation and Breathing Exercises After Abdominal Surgery at Sahlgrenska University Hospital (SUMO)
March 11, 2025 updated by: Göteborg University
The aim of the study is to evaluate the effect of a new care strategy, including earlier and more intensive mobilization and individually adapted breathing exercises, regarding length of stay, recovery, complications and which factors predict interventions early in the postoperative course after various abdominal surgical procedures.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monika Fagevik Olsén, PhD
- Phone Number: +46313421195
- Email: monika.fagevik-olsen@gu.se
Study Locations
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-
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Gothenburg, Sweden, 413 45
- Recruiting
- Sahlgrenska University Hospital
-
Contact:
- Monika Fagevik Olsén, PhD
- Phone Number: +46 707206189
- Email: monika.fagevik-olsen@vgregion.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients at Sahlgrenska university hospital.
Description
Inclusion Criteria:
- undergoing elective or emergency open, or robot-assisted abdominal surgery
- has an expected anesthesia time of over 4 hours
- is extubated on the operating table
- planned overnight stay in the postoperative ward.
Exclusion Criteria:
- plastic, trauma, transplant or orthopedic surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Standard practice
Routine of postoperative mobilisation and breathing exercises will recorded
|
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Optimised practice
Postoperative mobilisation and breathing exercises will be recorded after a co-creation process where optimal practice is defined and implemented
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time in postoperative care
Time Frame: At discharge from postoperative care up to two days after surgery.
|
Actual time from arrival to, to discharche from postoperative care.
|
At discharge from postoperative care up to two days after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first mobilisation
Time Frame: Up to the second postoperative day
|
Time from arrival to postoperative care to first mobilisation
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Up to the second postoperative day
|
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Time to start of breathing exercises
Time Frame: Up to the second postoperative day
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Time from arrival to postoperative care until start of specific breathing exercises.
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Up to the second postoperative day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of mobilisations
Time Frame: Up to the second postoperative day
|
Number of mobilisations
|
Up to the second postoperative day
|
|
Number of sessions of breathing exercises
Time Frame: Up to the second postoperative day
|
Number of sessions of breathing exercises
|
Up to the second postoperative day
|
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Time at hospital
Time Frame: At discharge from the hospital up to four weeks after surgery
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Time from the day of surgery to discharge from hospital.
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At discharge from the hospital up to four weeks after surgery
|
|
Type of mobilisation
Time Frame: Up to the second postoperative day
|
Registration of type of mobilisation
|
Up to the second postoperative day
|
|
Type of breathing exercises
Time Frame: Up to the second postoperative day
|
Type of breathing exercises prescribed
|
Up to the second postoperative day
|
|
Analgesia
Time Frame: Up to the second postoperative day
|
Type of analgesia
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Up to the second postoperative day
|
|
Complications
Time Frame: At discharge from the hospital up to four weeks after surgery.
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Postoperative pulmonary complications.
|
At discharge from the hospital up to four weeks after surgery.
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Dose of analgesia
Time Frame: Up to the second postoperative day
|
Dose of analgesia given
|
Up to the second postoperative day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
January 22, 2025
First Submitted That Met QC Criteria
February 4, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- FoU i VGR no: 284167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It is not included in the ethical approvement
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.