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Postoperative ComplicationsNCT03556059

Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

A study testing Role of EOSS in people with Postoperative Complications, run by Sana Klinikum Offenbach at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. 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 18 to 75 years
Conditions the study is for
Postoperative Complications
What is being tested?
Role of EOSS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,437 participants
Where
1 siteGermany
Study dates
Feb 2015to Dec 2018
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity
  • -

Who cannot join

  • previous obesity surgery
  • previous surgery of the upper gastrointestinal tract in anamnesis

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Sana Klinikum Offenbach

    Offenbach, 63069

Other trials in Germany

About this study

Official title: Procedure Selection in Obesity and Metabolic Surgery Based on the Edmonton Obesity Staging System (EOSS) - a Nationwide German Register-based Cohort Study (StuDoQ MBE)

The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.

The aim of this study is to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.

Read the detailed description

All patients in Germany, who underwent Sleeve Gastrectomy, Roux-en Y Gastric Bypass and Mini/One anastomosis Gastric Bypass as a primary procedure for severe obesity, are prospectively registered in the German register StuDoQ MBE.

Preoperative EOSS by Sharma et al. will be applied to all patients, who were operated between Februar 2015 and July 2017 by two different evaluators. Data collection will include the following: gender, age, body mass index, mobility, comorbidities, ASA score (American Society of Anesthesiologists score) perioperative complications next to Clavien Dindo, readmission rates and 30 - day mortality. Follow-up will be investigated in all patients up to 1 month after surgery.

Complications, readmission rates and 30 day mortality will be investigated in relation to EOSS and the surgical procedure performed, to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.

Being tested
Role of EOSS
Keywords
EOSS, Obesity and metabolic surgery, postoperative outcome, procedure selection
Medical subject headings
Postoperative Complications, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Role of EOSSOther

    The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.

Study groups in NCT03556059
Study groupRoleWhat they receive
RNYGBActive comparatorThe role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity
Receives: Other: Role of EOSS
SleeveActive comparatorThe role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity
Receives: Other: Role of EOSS
MGB/OAGBActive comparatorThe role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity
Receives: Other: Role of EOSS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative complications

    postoperative outcome after surgery next to the Clavien Dindo Classification

    Measured: 30 days after surgery

Secondary outcomes (13)

  1. postoperative complications related to surgical procedure

    postoperative complications related to surgical procedure

    Measured: 30 days after surgery

  2. postoperative complications related to Edmonton Obesity Staging System

    postoperative complications related to Edmonton Obesity Staging System

    Measured: 30 days after surgery

  3. ASA related to Edmonton Obesity Staging System

    ASA related to Edmonton Obesity Staging System

    Measured: prior to surgery

  4. Edmonton Obesity Staging System related to length of postoperative stay

    Edmonton Obesity Staging System related to length of postoperative stay

    Measured: 30 days after surgery

  5. Edmonton Obesity Staging System related to readmission

    Edmonton Obesity Staging System related to readmission

    Measured: 30 days after surgery

  6. Edmonton Obesity Staging System related gender

    Edmonton Obesity Staging System related gender

    Measured: 30 days after surgery

  7. Edmonton Obesity Staging System related to surgical procedure

    Edmonton Obesity Staging System related to surgical procedure

    Measured: 30 days after surgery

  8. postoperative complications related to ASA

    postoperative complications related to ASA

    Measured: 30 days after surgery

  9. postoperative complications related to gender

    postoperative complications related to gender

    Measured: 30 days after surgery

  10. age related to postoperative complications

    age related to postoperative complications

    Measured: 30 days after surgery

  11. Body Mass Index related to postoperative complications

    Body Mass Index related to postoperative complications

    Measured: 30 days after surgery

  12. Edmonton Obesity Staging System related to age

    Edmonton Obesity Staging System related to age

    Measured: 30 days after surgery

  13. Edmonton Obesity Staging System related to Body Mass Index

    Edmonton Obesity Staging System related to Body Mass Index

    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.

  1. First posted14 Jun 2018
  2. Study startFeb 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications
Masking
None (open label)
Enrolment
9,437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556059
Sponsor's protocol ID
FF 83_2/2015
Status last verified
Jan 2019
First submitted
18 May 2018
Last updated
24 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymous data will be published in a peer-reviewed journal.

Publications

  • Sharma 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

  • 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 21838602

  • Padwal 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 21844111

  • Gill 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 22002510

  • Chiappetta S, Stier C, Squillante S, Theodoridou S, Weiner RA. The importance of the Edmonton Obesity Staging System in predicting postoperative outcome and 30-day mortality after metabolic surgery. Surg Obes Relat Dis. 2016 Dec;12(10):1847-1855. doi: 10.1016/j.soard.2016.02.042. Epub 2016 Mar 2.

    PubMed 27317606

  • Chiappetta S, Stier C, Weiner RA; members of StuDoQ|MBE of Deutsche Gesellschaft fur Allgemein- und Viszeralchirurgie/StuDoQ. The Edmonton Obesity Staging System Predicts Perioperative Complications and Procedure Choice in Obesity and Metabolic Surgery-a German Nationwide Register-Based Cohort Study (StuDoQ|MBE). Obes Surg. 2019 Dec;29(12):3791-3799. doi: 10.1007/s11695-019-04015-y.

    PubMed 31264178

Questions about this trial

What is this clinical trial studying?

A study testing Role of EOSS in people with Postoperative Complications, 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 2 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: finished, as of the sponsor's last update on 24 Jan 2019. 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 complications (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 NCT03556059, which also lists 6 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 24 Jan 2019.

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