ObesityRAMOSPHYSSURGNCT01998815
Role and Mechanisms of Obesity Surgery
An observational study of Obesity and Bariatric Surgery, run by Göteborg University at 1 site in Sweden.
Trial summary
The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery. The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery, Physical Activity
- What is being tested?
- Laparoscopic Roux-en-Y gastric bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2015to 31 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All obese patients undergoing laparoscopic Roux-en-Y gastric bypass surgery at Sahlgrenska University Hospital in Gothenburg and Kärnssjukhuset in Skövde, Sweden.
Who may be able to join
- >18 y of age
- BMI >35
Who cannot join
- non-knowledgeable in Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role and Mechanisms of Obesity Surgery - Physical Activity and Other Predictors of Hospital Stay, Recovery and Complications After Obesity Surgery
The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery.
The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure.
Read more
The investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea.
First aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of QoL and normal physical function.
The second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.
- Conditions
- Obesity, Bariatric Surgery, Physical Activity, Post-operative Complications, Quality of Life
- Being tested
- Laparoscopic Roux-en-Y gastric bypass surgery
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-Y gastric bypass surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Laparoscopic Roux-en-Y gastric bypass Receives: Procedure: Laparoscopic Roux-en-Y gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative recovery and complications
Length of hospital stay, post-operative sick-leave, rate of post-operative complications; bleeding, anastomotic leakage, re-admission, re-operation, thromboembolic complications (deep-venous thrombosis, pulmonary embolism).
Measured: 30 days
Secondary outcomes (1)
Post-operative well-being and late complications
Post-operative well-being and late complications such as persistent gastrointestinal adverse symptoms abdominal discomfort, pain (measured using gastrointestinal symptom rating scale ;GSRS), dumping syndrome (measured by dumping syndrome rating scale), quality of life (SF-36 and EQ5d), physical activity level (Saltin Grimby), depression and anxiety rating (Hospital Depression and Anxiety rating scale), pain anxiety (Pain Catastrophizing scale).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study start1 Mar 2015
- Primary completion1 Dec 2017
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998815
- Sponsor's protocol ID
- Dnr 310-13
- Acronym
- RAMOSPHYSSURG
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2013
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Mechanisms of Obesity Surgery - Physical Activity and Other Predictors of Hospital Stay, Recovery and Complications After Obesity Surgery
- ClinicalTrials.gov ID
- NCT01998815
- Acronym / sponsor ID
- RAMOSPHYSSURG / Dnr 310-13
- Conditions
- Obesity, Bariatric Surgery, Physical Activity, Post-operative Complications, Quality of Life
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Dec 2013 (estimated)
- 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.
The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery.
The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure.
The investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea.
First aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of QoL and normal physical function.
The second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Procedure: Laparoscopic Roux-en-Y gastric bypass surgeryLaparoscopic Roux-en-Y gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All obese patients undergoing laparoscopic Roux-en-Y gastric bypass surgery at Sahlgrenska University Hospital in Gothenburg and Kärnssjukhuset in Skövde, Sweden.
Key inclusion criteria (2 listed)
- >18 y of age
- BMI >35
Key exclusion criteria (1 listed)
- non-knowledgeable in Swedish language
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 |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass surgery | Procedure or surgery | Obese patients |
Primary outcome
Post-operative recovery and complications
Time frame: 30 days
Length of hospital stay, post-operative sick-leave, rate of post-operative complications; bleeding, anastomotic leakage, re-admission, re-operation, thromboembolic complications (deep-venous thrombosis, pulmonary embolism).
1 secondary outcome
Post-operative well-being and late complications
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Scandinavian Surgical Outcomes Research Group homepageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and Bariatric Surgery, 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 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: paused, as of the sponsor's last update on 10 Dec 2021. 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?
Results are not available in the source record.
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?
Post-operative recovery and complications (time frame: 30 days). 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 10 Dec 2021.