ObesityNCT02947412
Long Term Results After Sleeve Gastrectomy
An observational study of Obesity, run by Sana Klinikum Offenbach.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- laparoscopic sleeve gastrectomy
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- s.a. sleeve gastrectomy since 2007
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- laparoscopic sleeve gastrectomy
- Keywords
- sleeve gastrectomy, long-term follow-up, gastroesophageal reflux disease after sleeve, revisional surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyOther
laparoscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| sleeve gastrectomy | laparoscopic sleeve gastrectomy Receives: Other: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of revisional surgery
Measured: up to 9 years after surgery
Secondary outcomes (2)
Excess weight loss in %
Measured: up to 9 years after surgery
Incidence of Gastroesophageal Reflux Disease
Measured: up to 9 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJan 2007
- Primary completionDec 2015
- Study completionOct 2016
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 ObesityStudies 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
- 40 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
- Rudolf A Weiner, Prof., Study director, Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947412
- Sponsor's protocol ID
- FF 1/2016
- Status last verified
- Apr 2018
- First submitted
- 26 Oct 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26316928Sarela 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.
PubMed 21890430Abelson 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.
PubMed 26660488Ramos 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.
PubMed 26537277Perrone 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.
PubMed 26033435
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
- Long Term Results After Sleeve Gastrectomy as a Primary Procedure in Obesity Surgery
- ClinicalTrials.gov ID
- NCT02947412
- Acronym / sponsor ID
- FF 1/2016
- Conditions
- Obesity
- Keywords
- sleeve gastrectomy, long-term follow-up, gastroesophageal reflux disease after sleeve, revisional surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Oct 2016 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sleeve gastrectomy | – | Other: laparoscopic sleeve gastrectomylaparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- s.a. sleeve gastrectomy since 2007
Key exclusion criteria (1 listed)
- -
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 sleeve gastrectomylaparoscopic sleeve gastrectomy | Other | sleeve gastrectomy |
Primary outcome
Incidence of revisional surgery
Time frame: up to 9 years after surgery
2 secondary outcomes
Excess weight loss in %
Time frame: up to 9 years after surgery
Incidence of Gastroesophageal Reflux Disease
Time frame: up to 9 years 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 26316928Biter 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.
- Background: PubMed 21890430Sarela 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.
- Results publication: PubMed 26660488Abelson 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.
- Results publication: PubMed 26537277Ramos 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.
- Results publication: PubMed 26033435Perrone 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.
- Individual participant dataSharing planned: No
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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.
Rudolf A Weiner, Prof. study director
Sana Klinikum Offenbach
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Sana Klinikum Offenbach.
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.
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?
Incidence of revisional surgery (time frame: up to 9 years 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 NCT02947412, 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 25 Apr 2018.