SurgeryEPOSNCT05630443
Effects of Prone Position After Major Abdominal Surgery
A study testing prone position in people with Surgery and Complications, Postoperative, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Complications, Postoperative, Lung Infection
- What is being tested?
- prone position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- malignancy of the esophagus, gastric- or pancreas
Who cannot join
- -.not able to understand Swedish in writing or speaking
- preoperatively unable to perform a prone position
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cecilia Engstrom Mattisson, MD PhD contact
About this study
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
Read the detailed description
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
The patients will be randomized to the standard ERAS-protocol, enhanced recovery after surgery with or without adding periods of prone position after surgery.
They will be followed by protocol both as a momentum effect (experimental study) on POD 2-5 and also POD 7.
The aim is evaluation of prone position in order to improve the ventilation and hopefully diminish the risk of for example pneumonia and thromboembolism.
Inclusion criteria Patients referred to the Department of Surgery for major abdominal surgery of the esophagus, gastric- or pancreas surgery aim to cure.
Exclusion criteria Patients unable to understand Swedish in writing or speaking, preoperatively unable to perform a prone position.
The participation is voluntary and demands an inform consent from the patient operated upon.
The primary outcome is oxygen saturation and lung complications after surgery.
The secondary outcome is measurement of lung volumes, patient experience (7th graded Lickert scale), days of hospital care, 30 days complications etc.
Further investigations are perioperative properties as BMI, other forms of surgery, etc., and continues measurement of blood pressure, respiration frequency, heartrate, tubes and drainages, postoperative analgesic, blood samples with signs of bleeding, inflammation, infection.
- Conditions
- Surgery, Complications, Postoperative, Lung Infection
- Being tested
- prone position
- Keywords
- complications postoperative, lungcomplications, abdominal surgery, prone position
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionProcedure or surgery
Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining
| Study group | Role | What they receive |
|---|---|---|
| ERAS | No intervention | Ordinary ERAS treatment postoperatively without any prone position or voicetraining |
| +prone position | Active comparator | Ordinary ERAS treatment adding the prone position and voicetraining in short intervals Receives: Procedure: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation measurement postoperatively
Measurement during sitting position
Measured: an average of (POD) Postoperative day 2-7
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis
Measured: through study completion, an average of 1 year
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications
Pneumonia, Lung embolism, Empyema of the lung, pankreatitis
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Number of participants with treatment-related diminished lung volumes
Spirometric measurements of diminished lung volumes
Measured: through study completion, an average of 1 year
Number of days of Hospital care
Days of inhouse treatment
Measured: through study completion, an average of 1 year
Number of participants needing intervention
Treament intervention like antibiotics or other medical or interventional treatment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cecilia Engström-Mattisson, Vastra Gotaland Region
- Investigators
- Cecilia Engstrom Mattisson, MD PhD, Principal investigator, Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630443
- Sponsor's protocol ID
- 2021-06877-01
- Acronym
- EPOS
- Status last verified
- May 2024
- First submitted
- 3 Jun 2022
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The template is only shared with the two invesitagtors in this application.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prone Position After Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05630443
- Acronym / sponsor ID
- EPOS / 2021-06877-01
- Conditions
- Surgery, Complications, Postoperative, Lung Infection
- Keywords
- complications postoperative, lungcomplications, abdominal surgery, prone position
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2022 (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.
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
Detailed description
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
The patients will be randomized to the standard ERAS-protocol, enhanced recovery after surgery with or without adding periods of prone position after surgery.
They will be followed by protocol both as a momentum effect (experimental study) on POD 2-5 and also POD 7.
The aim is evaluation of prone position in order to improve the ventilation and hopefully diminish the risk of for example pneumonia and thromboembolism.
Inclusion criteria Patients referred to the Department of Surgery for major abdominal surgery of the esophagus, gastric- or pancreas surgery aim to cure.
Exclusion criteria Patients unable to understand Swedish in writing or speaking, preoperatively unable to perform a prone position.
The participation is voluntary and demands an inform consent from the patient operated upon.
The primary outcome is oxygen saturation and lung complications after surgery.
The secondary outcome is measurement of lung volumes, patient experience (7th graded Lickert scale), days of hospital care, 30 days complications etc.
Further investigations are perioperative properties as BMI, other forms of surgery, etc., and continues measurement of blood pressure, respiration frequency, heartrate, tubes and drainages, postoperative analgesic, blood samples with signs of bleeding, inflammation, infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| ERAS | No intervention | –Ordinary ERAS treatment postoperatively without any prone position or voicetraining |
| +prone position | Active comparator | Procedure: prone positionOrdinary ERAS treatment adding the prone position and voicetraining in short intervals |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- malignancy of the esophagus, gastric- or pancreas
Key exclusion criteria (2 listed)
- -.not able to understand Swedish in writing or speaking
- preoperatively unable to perform a prone position
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 |
|---|---|---|
| prone positionOrdinary ERAS treatment postoperatvely adding the prone position and voicetraining | Procedure or surgery | +prone position |
Primary outcome
Oxygen saturation measurement postoperatively
Time frame: an average of (POD) Postoperative day 2-7
Measurement during sitting position
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
Time frame: through study completion, an average of 1 year
Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications
Time frame: through study completion, an average of 1 year
Pneumonia, Lung embolism, Empyema of the lung, pankreatitis
3 secondary outcomes
Number of participants with treatment-related diminished lung volumes
Time frame: through study completion, an average of 1 year
Number of days of Hospital care
Time frame: through study completion, an average of 1 year
Number of participants needing intervention
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. The template is only shared with the two invesitagtors in this application.
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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.
Cecilia Engstrom Mattisson, MD PhD contact
Cecilia Engstrom Mattisson, MD PhD principal investigator
Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone position in people with Surgery and Complications, Postoperative, run by Vastra Gotaland Region at 1 site in Sweden.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 May 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Engstrom Mattisson, MD PhD (+46704970393, cecilia.engstrom.@surgery.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation measurement postoperatively (time frame: an average of (POD) Postoperative day 2-7). 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?
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 30 May 2024.