BenchmarkBBenchmarksNCT03440138
Defining Benchmarks in Bariatric Surgery
An observational study of Benchmark and Bariatric Surgery, run by Marco Bueter at 1 site in Switzerland.
Trial summary
Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery. Design: Multicenter retrospective cohort study. Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benchmark, Bariatric Surgery, Roux-en-y Gastric Bypass
- What is being tested?
- bariatric surgery (RYGB or SG)
- Type of treatment
- Surgery or procedure
- How many people
- 5,741 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2017to 17 Sep 2019
- 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: Adult patients with severe obesity with a lower risk profile who undergo bariatric surgery
Who may be able to join
- Adult patients of 18-65 years
- Low risk profile (please read "exclusion criteria"),
- Maximum preoperative BMI of 50 kg/m2
- Primary laparoscopic/robotic proximal Roux-en-Y gastric bypass or sleeve gastrectomy
- Documented follow-up of at least 90 days
Who cannot join
- Open surgery
- Previous intra-abdominal surgery (including previous bariatric surgery)
- Pre-operative BMI over 50 kg/m2
- Age over 65 years
- Cardiovascular disease (e.g. cardiac arrhythmia, stroke, coronary artery disease) (Hypertension is allowed)
- History of thromboembolic events and/or therapeutic anticoagulation
Show all 14Show fewer
- Diabetes mellitus (Type I and Type II, as defined by the American Diabetes Association)
- Obstructive sleep apnea (recurrent episodes of upper airway collapse during sleep)
- Chronic obstructive pulmonary disease (FEV1/FVC<0.7)
- Chronic kidney disease (eGFR < 30ml/min/1.72 m2)
- Inflammatory bowel disease (ulcerative colitis, Crohn's)
- Immunosuppression therapy (e.g. steroids, calcineurin inhibitors, etc)
- Patients who underwent associated procedures (for example: cholecystectomy, hiatoplasty, liver biopsy)
- ASA score > 2
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Defining Benchmarks in Bariatric Surgery - A Global Analysis of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy
Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery.
Design: Multicenter retrospective cohort study.
Read more
Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest follow-up. Evolution of body mass index (BMI) will be also analyzed.
Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least three continents, maintaining a prospective database, as well as having published previously critically on their outcome.
Study population: Adult patients who underwent primary minimally invasive (laparoscopic / robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May 2017.
Patient Exclusion criteria: detailed later.
Data collection Deadline: 1st September 2017 - 30 April 2018
Read the detailed description
Background With the growing complexity and cost of modern surgical practice, quality assessment becomes mandatory. The notion of quality and quality assessment is widely recognized and used in the world of business and manufacturing. A possible tool of quality assessment is benchmarking. Benchmarking is a process of measuring performance by comparison to the outcomes achieved by the best "service provider" in a specific domain. Usually, a benchmark describes the ''best possible'' outcome of a benchmarking subject to whom comparison can be performed. In the surgical community, however, such benchmarks - best possible outcomes - for specific procedures, not just the pooled overall performance, are lacking.
In 2016, a first landmark study defining benchmark outcomes for liver resection was published in Annals of Surgery by a group of international authors invited and guided by our department. More recently, further surgical outcomes (liver transplantation, minimally invasive esophagectomy) have been benchmarked and have been accepted for publication.
Since laparoscopic bariatric surgery has become a standardized and widely performed procedure worldwide, quality assessment is of major importance. To identify the best possible outcomes (i.e. the benchmarks), data from high-volume centers (based on official IFSO criteria) in low risk patients will be analyzed. These benchmarks will serve as "optimal outcomes" for comparison with single center outcomes, high-risk patients and future developments.
Aim The primary aim is to define benchmark outcomes based on assessment of post procedural complications according to the Clavien-Dindo classification for surgical complications and the comprehensive complication index CCI™ at discharge and at 90-days. The CCI® expresses morbidity on a continuous numeric scale from 0 (no complications) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity. Secondary outcome measure are patient survival and excess BMI loss (EBMIL).
Data Security This multicenter international study is designed to harvest prospectively collected retrospective data via an encrypted (i.e. Secure Sockets Layer (SSL) protocol) online platform (https://bbenchmarks.org/) that meets Food and Drug Administration (FDA) standards and is accessible only by secured login membership.
Confidential center specific data: Centers' outcomes will be individually analyzed in a first step to screen for center-specific differences. Benchmarks will be computed from each center's results in a second step. No center-specific data will be published. Instead, all complications or adverse outcomes will be anonymously reported, as fractions of the total study population. Each center, of course, will be free to publish their own data, as they wish.
Further use of cohort data: Future studies based on the collected data may emerge from this multicenter study, such as comparing outcomes in patients with or without specific comorbidities with benchmark outcomes. For further data usage, additional ethics approval may be required.
- Being tested
- bariatric surgery (RYGB or SG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgery (RYGB or SG)Procedure or surgery
laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy for severe obesity
| Study group | Role | What they receive |
|---|---|---|
| University Hospital Zurich | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| St Pierre University Hospital, Brussels, Belgium | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Sana Klinikum, Offenbach, Germany | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Complutense University of Madrid, Spain | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Musgrove Park Hospital, Taunton, UK | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| University of Gothenburg, Sweden | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| AZ Sint-Jan Hospital in Bruges, Belgium | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Bristol | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Cleveland Clinic, Weston, Florida, USA | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Oswaldo Cruz German Hospital, Sao Paolo, Brazil | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Clínica Las Condes, Santiago, Chile | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Brown University, Providence Rhode Island | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Fresno Bariatric, CA, USA | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Rijnstate Hospital, Arnhem, The Netherlands | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| CHU Nice, France | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Claraspital Basel, Switzerland | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Gastro-Obeso-Center Advanced Med Inst, Brazil | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Hospital Dipreca Santiago Región Metropolitana , Chile | Not described Receives: Procedure: bariatric surgery (RYGB or SG) | |
| Medical University Wien, Austria | Not described Receives: Procedure: bariatric surgery (RYGB or SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benchmark outcomes (best achievable outcomes after bariatric surgery)
Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/)
Measured: 30 days postoperatively
Benchmark outcomes (best achievable outcomes after bariatric surgery)
Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/)
Measured: 90 days postoperatively
Benchmark outcomes (best achievable outcomes after bariatric surgery)
Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/)
Measured: 180 days postoperatively
Major complications after bariatric surgery
Clavien-Dindo grade > IIIa
Measured: 30 days postoperatively
Major complications after bariatric surgery
Clavien-Dindo grade > IIIa
Measured: 90 days postoperatively
Major complications after bariatric surgery
Clavien-Dindo grade > IIIa
Measured: 180 days postoperatively
Secondary outcomes (4)
Case-mix within centers
proportion of benchmark cases
Measured: 5 years
Excess weight loss after bariatric surgery
Body-mass index (kg/m2)
Measured: 1-year postoperatively
Excess weight loss after bariatric surgery
Body-mass index (kg/m2)
Measured: 3-years postoperatively
Excess weight loss after bariatric surgery
Body-mass index (kg/m2)
Measured: 5-years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start17 Oct 2017
- Primary completion10 Sep 2018
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BenchmarkStudies 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
- Retrospective
- Enrolment
- 5,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Bueter
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. med. Daniel Gero, Dr. med. Dimitri A. Raptis, PhD, Dr. med. Henner Schmidt
- Responsible party
- Sponsor-investigator, Marco Bueter, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440138
- Sponsor's protocol ID
- BASECnr_2017-01652
- Acronym
- BBenchmarks
- Status last verified
- Sep 2019
- First submitted
- 7 Feb 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the study is based on de-anonymised data, so it is impossible to backtrack it to a patient. only overall data will be shared, not individual data
Publications
Rossler F, Sapisochin G, Song G, Lin YH, Simpson MA, Hasegawa K, Laurenzi A, Sanchez Cabus S, Nunez MI, Gatti A, Beltrame MC, Slankamenac K, Greig PD, Lee SG, Chen CL, Grant DR, Pomfret EA, Kokudo N, Cherqui D, Olthoff KM, Shaked A, Garcia-Valdecasas JC, Lerut J, Troisi RI, De Santibanes M, Petrowsky H, Puhan MA, Clavien PA. Defining Benchmarks for Major Liver Surgery: A multicenter Analysis of 5202 Living Liver Donors. Ann Surg. 2016 Sep;264(3):492-500. doi: 10.1097/SLA.0000000000001849.
PubMed 27433909Muller X, Marcon F, Sapisochin G, Marquez M, Dondero F, Rayar M, Doyle MMB, Callans L, Li J, Nowak G, Allard MA, Jochmans I, Jacskon K, Beltrame MC, van Reeven M, Iesari S, Cucchetti A, Sharma H, Staiger RD, Raptis DA, Petrowsky H, de Oliveira M, Hernandez-Alejandro R, Pinna AD, Lerut J, Polak WG, de Santibanes E, de Santibanes M, Cameron AM, Pirenne J, Cherqui D, Adam RA, Ericzon BG, Nashan B, Olthoff K, Shaked A, Chapman WC, Boudjema K, Soubrane O, Paugam-Burtz C, Greig PD, Grant DR, Carvalheiro A, Muiesan P, Dutkowski P, Puhan M, Clavien PA. Defining Benchmarks in Liver Transplantation: A Multicenter Outcome Analysis Determining Best Achievable Results. Ann Surg. 2018 Mar;267(3):419-425. doi: 10.1097/SLA.0000000000002477.
PubMed 28885508Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
PubMed 23728278Gero D, Raptis DA, Vleeschouwers W, van Veldhuisen SL, Martin AS, Xiao Y, Galvao M, Giorgi M, Benois M, Espinoza F, Hollyman M, Lloyd A, Hosa H, Schmidt H, Garcia-Galocha JL, van de Vrande S, Chiappetta S, Menzo EL, Aboud CM, Luthy SG, Orchard P, Rothe S, Prager G, Pournaras DJ, Cohen R, Rosenthal R, Weiner R, Himpens J, Torres A, Higa K, Welbourn R, Berry M, Boza C, Iannelli A, Vithiananthan S, Ramos A, Olbers T, Sepulveda M, Hazebroek EJ, Dillemans B, Staiger RD, Puhan MA, Peterli R, Bueter M. Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Ann Surg. 2019 Nov;270(5):859-867. doi: 10.1097/SLA.0000000000003512.
PubMed 31592894
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Benchmarks in Bariatric Surgery - A Global Analysis of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03440138
- Acronym / sponsor ID
- BBenchmarks / BASECnr_2017-01652
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,741 participants (actual)
- Lead sponsor
- Marco BueterUniversity, hospital or other
- Collaborators
- Dr. med. Daniel Gero, Dr. med. Dimitri A. Raptis, PhD, Dr. med. Henner Schmidt
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 20 Feb 2018 (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.
Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery.
Design: Multicenter retrospective cohort study.
Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest follow-up. Evolution of body mass index (BMI) will be also analyzed.
Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least three continents, maintaining a prospective database, as well as having published previously critically on their outcome.
Study population: Adult patients who underwent primary minimally invasive (laparoscopic / robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May 2017.
Patient Exclusion criteria: detailed later.
Data collection Deadline: 1st September 2017 - 30 April 2018
Detailed description
Background With the growing complexity and cost of modern surgical practice, quality assessment becomes mandatory. The notion of quality and quality assessment is widely recognized and used in the world of business and manufacturing. A possible tool of quality assessment is benchmarking. Benchmarking is a process of measuring performance by comparison to the outcomes achieved by the best "service provider" in a specific domain. Usually, a benchmark describes the ''best possible'' outcome of a benchmarking subject to whom comparison can be performed. In the surgical community, however, such benchmarks - best possible outcomes - for specific procedures, not just the pooled overall performance, are lacking.
In 2016, a first landmark study defining benchmark outcomes for liver resection was published in Annals of Surgery by a group of international authors invited and guided by our department. More recently, further surgical outcomes (liver transplantation, minimally invasive esophagectomy) have been benchmarked and have been accepted for publication.
Since laparoscopic bariatric surgery has become a standardized and widely performed procedure worldwide, quality assessment is of major importance. To identify the best possible outcomes (i.e. the benchmarks), data from high-volume centers (based on official IFSO criteria) in low risk patients will be analyzed. These benchmarks will serve as "optimal outcomes" for comparison with single center outcomes, high-risk patients and future developments.
Aim The primary aim is to define benchmark outcomes based on assessment of post procedural complications according to the Clavien-Dindo classification for surgical complications and the comprehensive complication index CCI™ at discharge and at 90-days. The CCI® expresses morbidity on a continuous numeric scale from 0 (no complications) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity. Secondary outcome measure are patient survival and excess BMI loss (EBMIL).
Data Security This multicenter international study is designed to harvest prospectively collected retrospective data via an encrypted (i.e. Secure Sockets Layer (SSL) protocol) online platform (https://bbenchmarks.org/) that meets Food and Drug Administration (FDA) standards and is accessible only by secured login membership.
Confidential center specific data: Centers' outcomes will be individually analyzed in a first step to screen for center-specific differences. Benchmarks will be computed from each center's results in a second step. No center-specific data will be published. Instead, all complications or adverse outcomes will be anonymously reported, as fractions of the total study population. Each center, of course, will be free to publish their own data, as they wish.
Further use of cohort data: Future studies based on the collected data may emerge from this multicenter study, such as comparing outcomes in patients with or without specific comorbidities with benchmark outcomes. For further data usage, additional ethics approval may be required.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| University Hospital Zurich | – | Procedure: bariatric surgery (RYGB or SG) |
| St Pierre University Hospital, Brussels, Belgium | – | Procedure: bariatric surgery (RYGB or SG) |
| Sana Klinikum, Offenbach, Germany | – | Procedure: bariatric surgery (RYGB or SG) |
| Complutense University of Madrid, Spain | – | Procedure: bariatric surgery (RYGB or SG) |
| Musgrove Park Hospital, Taunton, UK | – | Procedure: bariatric surgery (RYGB or SG) |
| University of Gothenburg, Sweden | – | Procedure: bariatric surgery (RYGB or SG) |
| AZ Sint-Jan Hospital in Bruges, Belgium | – | Procedure: bariatric surgery (RYGB or SG) |
| Bristol | – | Procedure: bariatric surgery (RYGB or SG) |
| Cleveland Clinic, Weston, Florida, USA | – | Procedure: bariatric surgery (RYGB or SG) |
| Oswaldo Cruz German Hospital, Sao Paolo, Brazil | – | Procedure: bariatric surgery (RYGB or SG) |
| Clínica Las Condes, Santiago, Chile | – | Procedure: bariatric surgery (RYGB or SG) |
| Brown University, Providence Rhode Island | – | Procedure: bariatric surgery (RYGB or SG) |
| Fresno Bariatric, CA, USA | – | Procedure: bariatric surgery (RYGB or SG) |
| Rijnstate Hospital, Arnhem, The Netherlands | – | Procedure: bariatric surgery (RYGB or SG) |
| CHU Nice, France | – | Procedure: bariatric surgery (RYGB or SG) |
| Claraspital Basel, Switzerland | – | Procedure: bariatric surgery (RYGB or SG) |
| Gastro-Obeso-Center Advanced Med Inst, Brazil | – | Procedure: bariatric surgery (RYGB or SG) |
| Hospital Dipreca Santiago Región Metropolitana , Chile | – | Procedure: bariatric surgery (RYGB or SG) |
| Medical University Wien, Austria | – | Procedure: bariatric surgery (RYGB or SG) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe obesity with a lower risk profile who undergo bariatric surgery
Key inclusion criteria (5 listed)
- Adult patients of 18-65 years
- Low risk profile (please read "exclusion criteria"),
- Maximum preoperative BMI of 50 kg/m2
- Primary laparoscopic/robotic proximal Roux-en-Y gastric bypass or sleeve gastrectomy
- Documented follow-up of at least 90 days
Key exclusion criteria (14 listed)
- Open surgery
- Previous intra-abdominal surgery (including previous bariatric surgery)
- Pre-operative BMI over 50 kg/m2
- Age over 65 years
- Cardiovascular disease (e.g. cardiac arrhythmia, stroke, coronary artery disease) (Hypertension is allowed)
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 |
|---|---|---|
| bariatric surgery (RYGB or SG)laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy for severe obesity | Procedure or surgery | AZ Sint-Jan Hospital in Bruges, Belgium, Bristol, Brown University, Providence Rhode Island, CHU Nice, France, Claraspital Basel, Switzerland, Cleveland Clinic, Weston, Florida, USA, Clínica Las Condes, Santiago, Chile, Complutense University of Madrid, Spain, Fresno Bariatric, CA, USA, Gastro-Obeso-Center Advanced Med Inst, Brazil, Hospital Dipreca Santiago Región Metropolitana , Chile, Medical University Wien, Austria, Musgrove Park Hospital, Taunton, UK, Oswaldo Cruz German Hospital, Sao Paolo, Brazil, Rijnstate Hospital, Arnhem, The Netherlands, Sana Klinikum, Offenbach, Germany, St Pierre University Hospital, Brussels, Belgium, University Hospital Zurich, University of Gothenburg, Sweden |
Primary outcome
Benchmark outcomes (best achievable outcomes after bariatric surgery)
Time frame: 30 days postoperatively
Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/)
Benchmark outcomes (best achievable outcomes after bariatric surgery)
Time frame: 90 days postoperatively
Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/)
Benchmark outcomes (best achievable outcomes after bariatric surgery)
Time frame: 180 days postoperatively
Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/)
Major complications after bariatric surgery
Time frame: 30 days postoperatively
Clavien-Dindo grade > IIIa
Major complications after bariatric surgery
Time frame: 90 days postoperatively
Clavien-Dindo grade > IIIa
Major complications after bariatric surgery
Time frame: 180 days postoperatively
Clavien-Dindo grade > IIIa
4 secondary outcomes
Case-mix within centers
Time frame: 5 years
Excess weight loss after bariatric surgery
Time frame: 1-year postoperatively
Excess weight loss after bariatric surgery
Time frame: 3-years postoperatively
Excess weight loss after bariatric surgery
Time frame: 5-years postoperatively
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 19 Sep 2019.
- Background: PubMed 27433909Rossler F, Sapisochin G, Song G, Lin YH, Simpson MA, Hasegawa K, Laurenzi A, Sanchez Cabus S, Nunez MI, Gatti A, Beltrame MC, Slankamenac K, Greig PD, Lee SG, Chen CL, Grant DR, Pomfret EA, Kokudo N, Cherqui D, Olthoff KM, Shaked A, Garcia-Valdecasas JC, Lerut J, Troisi RI, De Santibanes M, Petrowsky H, Puhan MA, Clavien PA. Defining Benchmarks for Major Liver Surgery: A multicenter Analysis of 5202 Living Liver Donors. Ann Surg. 2016 Sep;264(3):492-500. doi: 10.1097/SLA.0000000000001849.
- Background: PubMed 28885508Muller X, Marcon F, Sapisochin G, Marquez M, Dondero F, Rayar M, Doyle MMB, Callans L, Li J, Nowak G, Allard MA, Jochmans I, Jacskon K, Beltrame MC, van Reeven M, Iesari S, Cucchetti A, Sharma H, Staiger RD, Raptis DA, Petrowsky H, de Oliveira M, Hernandez-Alejandro R, Pinna AD, Lerut J, Polak WG, de Santibanes E, de Santibanes M, Cameron AM, Pirenne J, Cherqui D, Adam RA, Ericzon BG, Nashan B, Olthoff K, Shaked A, Chapman WC, Boudjema K, Soubrane O, Paugam-Burtz C, Greig PD, Grant DR, Carvalheiro A, Muiesan P, Dutkowski P, Puhan M, Clavien PA. Defining Benchmarks in Liver Transplantation: A Multicenter Outcome Analysis Determining Best Achievable Results. Ann Surg. 2018 Mar;267(3):419-425. doi: 10.1097/SLA.0000000000002477.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 23728278Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
- Derived from this study: PubMed 31592894Gero D, Raptis DA, Vleeschouwers W, van Veldhuisen SL, Martin AS, Xiao Y, Galvao M, Giorgi M, Benois M, Espinoza F, Hollyman M, Lloyd A, Hosa H, Schmidt H, Garcia-Galocha JL, van de Vrande S, Chiappetta S, Menzo EL, Aboud CM, Luthy SG, Orchard P, Rothe S, Prager G, Pournaras DJ, Cohen R, Rosenthal R, Weiner R, Himpens J, Torres A, Higa K, Welbourn R, Berry M, Boza C, Iannelli A, Vithiananthan S, Ramos A, Olbers T, Sepulveda M, Hazebroek EJ, Dillemans B, Staiger RD, Puhan MA, Peterli R, Bueter M. Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Ann Surg. 2019 Nov;270(5):859-867. doi: 10.1097/SLA.0000000000003512.
- Individual participant dataSharing planned: No. the study is based on de-anonymised data, so it is impossible to backtrack it to a patient. only overall data will be shared, not individual data
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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 Benchmark and Bariatric Surgery, run by Marco Bueter at 1 site in Switzerland.
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 5 inclusion and 14 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 19 Sep 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 Switzerland. 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?
Benchmark outcomes (best achievable outcomes after bariatric surgery) (time frame: 30 days postoperatively). 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 NCT03440138, which also lists 5 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 19 Sep 2019.