Long Term Results After Sleeve Gastrectomy
April 24, 2018 updated by: Sonja Chiappetta, MD, Sana Klinikum Offenbach
Long Term Results After Sleeve Gastrectomy as a Primary Procedure in Obesity Surgery
Today sleeve gastrectomy is the most performed bariatric procedure worldwide.
Since 2005 it is gaining popularity as a single procedure.
Long term data is scarce.
In this retrospective study long term follow-up in relation to weight loss, comorbidities, re-do and revisional surgery is getting analyzed.
Study Overview
Detailed Description
Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce.
Re-Do and revisional surgery in form of re-sleeve, gastric bypass (mini -gastric bypass, roux-en y gastric bypass) and biliopancreatic diversion (BPD) is described in the current literature due to weight regain and reflux. The investigators want to analyze the frequency of this re-do/revisional surgery and want to compare weight loss and improvement in comorbidities.
Study Type
Observational
Enrollment (Actual)
40
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who underwent sleeve gastrectomy since 2007, being the first szrgical treatment for severe obesity are studied in the long term follow-up
Description
Inclusion Criteria:
- s.a. sleeve gastrectomy since 2007
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
sleeve gastrectomy
laparoscopic sleeve gastrectomy
|
laparoscopic sleeve gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of revisional surgery
Time Frame: up to 9 years after surgery
|
up to 9 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Excess weight loss in %
Time Frame: up to 9 years after surgery
|
up to 9 years after surgery
|
|
Incidence of Gastroesophageal Reflux Disease
Time Frame: up to 9 years after surgery
|
up to 9 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rudolf A Weiner, Prof., Sana Klinikum Offenbach
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Biter LU, Gadiot RP, Grotenhuis BA, Dunkelgrun M, van Mil SR, Zengerink HJ, Smulders JF, Mannaerts GH. The Sleeve Bypass Trial: a multicentre randomized controlled trial comparing the long term outcome of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity in terms of excess BMI loss percentage and quality of life. BMC Obes. 2015 Aug 26;2:30. doi: 10.1186/s40608-015-0058-0. eCollection 2015.
- Sarela AI, Dexter SP, O'Kane M, Menon A, McMahon MJ. Long-term follow-up after laparoscopic sleeve gastrectomy: 8-9-year results. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):679-84. doi: 10.1016/j.soard.2011.06.020. Epub 2011 Jul 20.
- Abelson JS, Afaneh C, Dolan P, Chartrand G, Dakin G, Pomp A. Laparoscopic Sleeve Gastrectomy: Co-morbidity Profiles and Intermediate-Term Outcomes. Obes Surg. 2016 Aug;26(8):1788-93. doi: 10.1007/s11695-015-2002-2.
- Ramos AC, Bastos EL, Ramos MG, Bertin NT, Galvao TD, de Lucena RT, Campos JM. MEDIUM-TERM FOLLOW-UP RESULTS WITH LAPAROSCOPIC SLEEVE GASTRECTOMY. Arq Bras Cir Dig. 2015;28 Suppl 1(Suppl 1):61-4. doi: 10.1590/S0102-6720201500S100017.
- Perrone F, Bianciardi E, Benavoli D, Tognoni V, Niolu C, Siracusano A, Gaspari AL, Gentileschi P. Gender Influence on Long-Term Weight Loss and Comorbidities After Laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: a Prospective Study With a 5-Year Follow-up. Obes Surg. 2016 Feb;26(2):276-81. doi: 10.1007/s11695-015-1746-z.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
October 26, 2016
First Submitted That Met QC Criteria
October 26, 2016
First Posted (Estimate)
October 27, 2016
Study Record Updates
Last Update Posted (Actual)
April 25, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FF 1/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.