Postoperative ComplicationsNCT02607267
Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality
An observational study of Postoperative Complications and Other Complications of Other Bariatric Procedure, run by Sana Klinikum Offenbach at 1 site in Germany.
Trial summary
The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. The aim of this study is to determine whether the EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery. Read more about this study
- Who is it for?
- Ages 19 to 73 years
- Conditions the study is for
- Postoperative Complications, Other Complications of Other Bariatric Procedure
- What is being tested?
- LSG and LRYGB
- How many people
- 534 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Jan 2016
- 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 19 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for severe obesity
Who may be able to join
- patients undergoing either LSG or LRYGB, being the first surgical treatment for severe obesity
Who cannot join
- bariatric surgery in the anamnesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of the Edmonton Obesity Score System in Predicting Postoperative Outcome and 30 Day Mortality After Metabolic Surgery
The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. The aim of this study is to determine whether the EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.
Read the detailed description
From October 2014 to December 2015 the investigators conducted a prospective data collection on patients undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Gastric Bypass (Laparoscopic Roux-en-Y-Gastric Bypass (LRYGB) and Omega-Loop-Gastric-Bypass (LOLGB)), being the first surgical treatment for severe obesity. Preoperative EOSS by Sharma et al. was applied to all patients by two different evaluators. Data collection included the following: gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early - postoperative complications, readmission rates and 30 - day mortality. Follow-up was performed in all patients up to 1 month after surgery.
- Being tested
- LSG and LRYGB
- Keywords
- EOSS, Metabolic Surgery, postoperative outcome, 30 - day mortality
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSG and LRYGBOther
The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic Roux en Y Gastric Bypass | patients undergoing LRYGB, being the first surgical treatment for severe obesity Receives: Other: LSG and LRYGB | |
| laparoscopic Sleeve Gastrectomy | patients undergoing LSG, being the first surgical treatment for severe obesity Receives: Other: LSG and LRYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative outcome related to EOSS
Measured: 30 days after surgery
Secondary outcomes (4)
postoperative complications related to EOSS
Measured: 30 days after surgery
readmission rates related to EOSS
Measured: 30 days after surgery
age related to postoperative complications
Measured: 30 days after surgery
BMI related to postoperative complications
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionJan 2016
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 Postoperative ComplicationsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonja Chiappetta, MD, Sana Klinikum Offenbach
- Investigators
- Christine Stier, MD, Study director, Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607267
- Sponsor's protocol ID
- FF 83/2015
- Status last verified
- Apr 2018
- First submitted
- 16 Nov 2015
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuk JL, Ardern CI, Church TS, Sharma AM, Padwal R, Sui X, Blair SN. Edmonton Obesity Staging System: association with weight history and mortality risk. Appl Physiol Nutr Metab. 2011 Aug;36(4):570-6. doi: 10.1139/h11-058. Epub 2011 Aug 14.
PubMed 21838602Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using the Edmonton obesity staging system to predict mortality in a population-representative cohort of people with overweight and obesity. CMAJ. 2011 Oct 4;183(14):E1059-66. doi: 10.1503/cmaj.110387. Epub 2011 Aug 15.
PubMed 21844111Gill RS, Karmali S, Sharma AM. The potential role of the Edmonton obesity staging system in determining indications for bariatric surgery. Obes Surg. 2011 Dec;21(12):1947-9. doi: 10.1007/s11695-011-0533-8. No abstract available.
PubMed 22002510Sharma AM, Kushner RF. A proposed clinical staging system for obesity. Int J Obes (Lond). 2009 Mar;33(3):289-95. doi: 10.1038/ijo.2009.2. Epub 2009 Feb 3.
PubMed 19188927
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of the Edmonton Obesity Score System in Predicting Postoperative Outcome and 30 Day Mortality After Metabolic Surgery
- ClinicalTrials.gov ID
- NCT02607267
- Acronym / sponsor ID
- FF 83/2015
- Keywords
- EOSS, Metabolic Surgery, postoperative outcome, 30 - day mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Nov 2015 (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 Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. The aim of this study is to determine whether the EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.
Detailed description
From October 2014 to December 2015 the investigators conducted a prospective data collection on patients undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Gastric Bypass (Laparoscopic Roux-en-Y-Gastric Bypass (LRYGB) and Omega-Loop-Gastric-Bypass (LOLGB)), being the first surgical treatment for severe obesity. Preoperative EOSS by Sharma et al. was applied to all patients by two different evaluators. Data collection included the following: gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early - postoperative complications, readmission rates and 30 - day mortality. Follow-up was performed in all patients up to 1 month after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic Roux en Y Gastric Bypass | – | Other: LSG and LRYGBpatients undergoing LRYGB, being the first surgical treatment for severe obesity |
| laparoscopic Sleeve Gastrectomy | – | Other: LSG and LRYGBpatients undergoing LSG, being the first surgical treatment for severe obesity |
Who may qualify
- Ages
- 19 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for severe obesity
Key inclusion criteria (1 listed)
- patients undergoing either LSG or LRYGB, being the first surgical treatment for severe obesity
Key exclusion criteria (1 listed)
- bariatric surgery in the anamnesis
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 |
|---|---|---|
| LSG and LRYGBThe role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB) | Other | laparoscopic Roux en Y Gastric Bypass, laparoscopic Sleeve Gastrectomy |
Primary outcome
postoperative outcome related to EOSS
Time frame: 30 days after surgery
4 secondary outcomes
postoperative complications related to EOSS
Time frame: 30 days after surgery
readmission rates related to EOSS
Time frame: 30 days after surgery
age related to postoperative complications
Time frame: 30 days after surgery
BMI related to postoperative complications
Time frame: 30 days after surgery
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 25 Apr 2018.
- Background: PubMed 21838602Kuk JL, Ardern CI, Church TS, Sharma AM, Padwal R, Sui X, Blair SN. Edmonton Obesity Staging System: association with weight history and mortality risk. Appl Physiol Nutr Metab. 2011 Aug;36(4):570-6. doi: 10.1139/h11-058. Epub 2011 Aug 14.
- Background: PubMed 21844111Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using the Edmonton obesity staging system to predict mortality in a population-representative cohort of people with overweight and obesity. CMAJ. 2011 Oct 4;183(14):E1059-66. doi: 10.1503/cmaj.110387. Epub 2011 Aug 15.
- Background: PubMed 22002510Gill RS, Karmali S, Sharma AM. The potential role of the Edmonton obesity staging system in determining indications for bariatric surgery. Obes Surg. 2011 Dec;21(12):1947-9. doi: 10.1007/s11695-011-0533-8. No abstract available.
- Results publication: PubMed 19188927Sharma AM, Kushner RF. A proposed clinical staging system for obesity. Int J Obes (Lond). 2009 Mar;33(3):289-95. doi: 10.1038/ijo.2009.2. Epub 2009 Feb 3.
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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.
Christine Stier, MD study director
Sana Klinikum Offenbach
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 Postoperative Complications and Other Complications of Other Bariatric Procedure, run by Sana Klinikum Offenbach at 1 site in Germany.
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 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 25 Apr 2018. 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 Germany. 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?
postoperative outcome related to EOSS (time frame: 30 days after surgery). 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 NCT02607267, 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 25 Apr 2018.