Abdominal CancerSOMBATANCT04729634
Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery
A study testing Mobilization in people with Abdominal Cancer and Heart Diseases, run by Göteborg University at 1 site in Sweden.
Trial summary
Background Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Cancer, Heart Diseases
- What is being tested?
- Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,492 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- undergoing a planned or acute open, laparoscopic or robot-assisted surgeon in the thorax or abdomen
- who are extubated within 24 h of surgery
- breathe spontaneously within 24 h of surgery
Who cannot join
- reconstructive-, trauma-, transplantation- or orthopedic surgery.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41345
About this study
Background
Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains.
Read more
Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations.
The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed
Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery.
The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks.
Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.
- Conditions
- Abdominal Cancer, Heart Diseases
- Being tested
- Mobilization
- Keywords
- Immobilization, Abdominal surgery, Thoracic surgery, Breathing training
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationOther
Also called Breathing training
Mobilization and breathing exercises according to clinical care
| Study group | Role | What they receive |
|---|---|---|
| Mobilization and breathing training | Other | Usual clinical care Receives: Other: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
When mobilization starts after surgery
Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed
Measured: Within 24 hours after surgery
Mobilization- Content
Content of the mobilization performed i.e. which level of mobilization (sitting on the edge of the bed, standing by the bed, sitting in a chair and walking) which is reached.
Measured: Within 24 hours after surgery
Mobilization- Duration
Duration of the mobilization performed, minutes
Measured: Within 24 hours after surgery
When any intervention with breathing exercises starts after surgery
Time from termination of anesthesia to when the breathing exercise starts
Measured: Within 24 hours after surgery
Breathing exercise- Content
Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
Measured: Within 24 hours after surgery
Breathing exercise- Intensity
Intensity of breathing exercise prescribed, sessions/time.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A cohort of patients followed over time
- Masking
- None (open label)
- Enrolment
- 1,492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Fagevik Olsén, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729634
- Sponsor's protocol ID
- FoU i VGR: 275327
- Acronym
- SOMBATA
- Status last verified
- Aug 2022
- First submitted
- 4 Jan 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fagevik Olsen M, Sehlin M, Westerdahl E, Svensson-Raskh A, Block L, Engstrom C, Nygren-Bonnier M, Schandl A. Timeframes for "early" mobilisation after abdominal and cardiothoracic surgery: evidence- and consensus-based suggestions of definitions. BMC Surg. 2026 Apr 18;26(1):281. doi: 10.1186/s12893-026-03729-y.
PubMed 41998647Fagevik Olsen M, Svensson-Raskh A, Westerdahl E, Nygren Bonnier M, Reeve J, Sehlin M. Current practice of targeted breathing exercises after abdominal and cardiothoracic surgery: a national multicentre observational study. Physiotherapy. 2025 Jun;127:101462. doi: 10.1016/j.physio.2024.101462. Epub 2024 Dec 24.
PubMed 39946932Westerdahl E, Lilliecrona J, Sehlin M, Svensson-Raskh A, Nygren-Bonnier M, Olsen MF. First initiation of mobilization out of bed after cardiac surgery - an observational cross-sectional study in Sweden. J Cardiothorac Surg. 2024 Jul 4;19(1):420. doi: 10.1186/s13019-024-02915-4.
PubMed 38961385Fagevik Olsen M, Sehlin M, Westerdahl E, Schandl A, Block L, Nygren-Bonnier M, Svensson-Raskh A. First mobilisation after abdominal and cardiothoracic surgery: when is it actually performed? A national, multicentre, cross-sectional study. BMJ Open. 2024 Feb 29;14(2):e082239. doi: 10.1136/bmjopen-2023-082239.
PubMed 38423778
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04729634
- Acronym / sponsor ID
- SOMBATA / FoU i VGR: 275327
- Conditions
- Abdominal Cancer, Heart Diseases
- Keywords
- Immobilization, Abdominal surgery, Thoracic surgery, Breathing training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,492 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Jan 2021 (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.
Background
Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains.
Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations.
The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed
Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery.
The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks.
Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A cohort of patients followed over time
| Arm | Type | Receives |
|---|---|---|
| Mobilization and breathing training | Other | Other: MobilizationUsual clinical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- undergoing a planned or acute open, laparoscopic or robot-assisted surgeon in the thorax or abdomen
- who are extubated within 24 h of surgery
- breathe spontaneously within 24 h of surgery
Key exclusion criteria (1 listed)
- reconstructive-, trauma-, transplantation- or orthopedic surgery.
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 |
|---|---|---|
| MobilizationAlso: Breathing trainingMobilization and breathing exercises according to clinical care | Other | Mobilization and breathing training |
Primary outcome
When mobilization starts after surgery
Time frame: Within 24 hours after surgery
Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed
Mobilization- Content
Time frame: Within 24 hours after surgery
Content of the mobilization performed i.e. which level of mobilization (sitting on the edge of the bed, standing by the bed, sitting in a chair and walking) which is reached.
Mobilization- Duration
Time frame: Within 24 hours after surgery
Duration of the mobilization performed, minutes
When any intervention with breathing exercises starts after surgery
Time frame: Within 24 hours after surgery
Time from termination of anesthesia to when the breathing exercise starts
Breathing exercise- Content
Time frame: Within 24 hours after surgery
Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
Breathing exercise- Intensity
Time frame: Within 24 hours after surgery
Intensity of breathing exercise prescribed, sessions/time.
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 16 Aug 2022.
- Derived from this study: PubMed 41998647Fagevik Olsen M, Sehlin M, Westerdahl E, Svensson-Raskh A, Block L, Engstrom C, Nygren-Bonnier M, Schandl A. Timeframes for "early" mobilisation after abdominal and cardiothoracic surgery: evidence- and consensus-based suggestions of definitions. BMC Surg. 2026 Apr 18;26(1):281. doi: 10.1186/s12893-026-03729-y.
- Derived from this study: PubMed 39946932Fagevik Olsen M, Svensson-Raskh A, Westerdahl E, Nygren Bonnier M, Reeve J, Sehlin M. Current practice of targeted breathing exercises after abdominal and cardiothoracic surgery: a national multicentre observational study. Physiotherapy. 2025 Jun;127:101462. doi: 10.1016/j.physio.2024.101462. Epub 2024 Dec 24.
- Derived from this study: PubMed 38961385Westerdahl E, Lilliecrona J, Sehlin M, Svensson-Raskh A, Nygren-Bonnier M, Olsen MF. First initiation of mobilization out of bed after cardiac surgery - an observational cross-sectional study in Sweden. J Cardiothorac Surg. 2024 Jul 4;19(1):420. doi: 10.1186/s13019-024-02915-4.
- Derived from this study: PubMed 38423778Fagevik Olsen M, Sehlin M, Westerdahl E, Schandl A, Block L, Nygren-Bonnier M, Svensson-Raskh A. First mobilisation after abdominal and cardiothoracic surgery: when is it actually performed? A national, multicentre, cross-sectional study. BMJ Open. 2024 Feb 29;14(2):e082239. doi: 10.1136/bmjopen-2023-082239.
Related trials for Abdominal Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
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.
Monika Fagevik Olsén, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization in people with Abdominal Cancer and Heart Diseases, run by Göteborg University 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 4 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 16 Aug 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 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?
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?
When mobilization starts after surgery (time frame: Within 24 hours after surgery). The study lists 6 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 NCT04729634, which also lists 4 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 16 Aug 2022.