ObesityNCT03526783
MGB/OAGB Versus RYGB After Failed Sleeve
A study testing Roux en Y gastric bypass and Mini/One anastomosis gastric bypass in people with Obesity, run by Sana Klinikum Offenbach at 1 site in Germany.
Trial summary
Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Roux en Y gastric bypass and Mini/One anastomosis gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Sep 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
- Patients with failed sleeve due to
- weight regain
- weight loss failure
- gastro-esophageal reflux disease Grade B
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy
Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease.
This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.
Read the detailed description
All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra- and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year follow-up.
- Conditions
- Obesity
- Being tested
- Roux en Y gastric bypass, Mini/One anastomosis gastric bypass
- Keywords
- Obesity Surgery, Failed Sleeve Gastrectomy, Roux-en-Y gastric bypass, Mini/One anastomosis gastric bypass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux en Y gastric bypassProcedure or surgery
Also called RNYGB
Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)
Mini/One anastomosis gastric bypassProcedure or surgery
Also called MGB/OAGB
Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)
| Study group | Role | What they receive |
|---|---|---|
| Failed sleeve gastrectomy - RNYGB | Other | Intervention: Roux en Y gasric bypass (RNYGB) Receives: Procedure: Roux en Y gastric bypass |
| Failed sleeve gastrectomy - MGB/OAGB | Other | Inervention: Mini/One anastomosis gasic bypass (MGB/OAGB) Receives: Procedure: Mini/One anastomosis gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Total Body Weight Loss in %
Measured: 1 year follow-up
Weight Loss
Excess Weight Loss in %
Measured: 1 year follow-up
Secondary outcomes (2)
Perioperative Complications
Perioperative Complications (Clavin-Dindo)
Measured: up to 30 days postsurgery
Postoperative Morbidity
Postoperative Morbidity
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study startOct 2014
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 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
- Sonja Chiappetta, MD, Principal investigator, Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526783
- Sponsor's protocol ID
- FF 3/2018
- Status last verified
- Sep 2018
- First submitted
- 23 Apr 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous data will be published.
Publications
Almalki OM, Lee WJ, Chen JC, Ser KH, Lee YC, Chen SC. Revisional Gastric Bypass for Failed Restrictive Procedures: Comparison of Single-Anastomosis (Mini-) and Roux-en-Y Gastric Bypass. Obes Surg. 2018 Apr;28(4):970-975. doi: 10.1007/s11695-017-2991-0.
PubMed 29101719Sarela 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 21890430Felsenreich DM, Kefurt R, Schermann M, Beckerhinn P, Kristo I, Krebs M, Prager G, Langer FB. Reflux, Sleeve Dilation, and Barrett's Esophagus after Laparoscopic Sleeve Gastrectomy: Long-Term Follow-Up. Obes Surg. 2017 Dec;27(12):3092-3101. doi: 10.1007/s11695-017-2748-9.
PubMed 28593484Weiner RA, Theodoridou S, Weiner S. Failure of laparoscopic sleeve gastrectomy--further procedure? Obes Facts. 2011;4 Suppl 1(Suppl 1):42-6. doi: 10.1159/000327343. Epub 2011 Apr 4.
PubMed 22027290Casillas RA, Um SS, Zelada Getty JL, Sachs S, Kim BB. Revision of primary sleeve gastrectomy to Roux-en-Y gastric bypass: indications and outcomes from a high-volume center. Surg Obes Relat Dis. 2016 Dec;12(10):1817-1825. doi: 10.1016/j.soard.2016.09.038. Epub 2016 Oct 4.
PubMed 27887931Disse E, Pasquer A, Espalieu P, Poncet G, Gouillat C, Robert M. Greater weight loss with the omega loop bypass compared to the Roux-en-Y gastric bypass: a comparative study. Obes Surg. 2014 Jun;24(6):841-6. doi: 10.1007/s11695-014-1180-7.
PubMed 24442421
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03526783
- Acronym / sponsor ID
- FF 3/2018
- Conditions
- Obesity
- Keywords
- Obesity Surgery, Failed Sleeve Gastrectomy, Roux-en-Y gastric bypass, Mini/One anastomosis gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 May 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.
Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease.
This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.
Detailed description
All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra- and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Failed sleeve gastrectomy - RNYGB | Other | Procedure: Roux en Y gastric bypassIntervention: Roux en Y gasric bypass (RNYGB) |
| Failed sleeve gastrectomy - MGB/OAGB | Other | Procedure: Mini/One anastomosis gastric bypassInervention: Mini/One anastomosis gasic bypass (MGB/OAGB) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with failed sleeve due to
- weight regain
- weight loss failure
- gastro-esophageal reflux disease Grade B
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 |
|---|---|---|
| Roux en Y gastric bypassAlso: RNYGBLaparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb) | Procedure or surgery | Failed sleeve gastrectomy - RNYGB |
| Mini/One anastomosis gastric bypassAlso: MGB/OAGBLaparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb) | Procedure or surgery | Failed sleeve gastrectomy - MGB/OAGB |
Primary outcome
Weight Loss
Time frame: 1 year follow-up
Total Body Weight Loss in %
Weight Loss
Time frame: 1 year follow-up
Excess Weight Loss in %
2 secondary outcomes
Perioperative Complications
Time frame: up to 30 days postsurgery
Postoperative Morbidity
Time frame: 1 year follow-up
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 2 Oct 2018.
- Results publication: PubMed 29101719Almalki OM, Lee WJ, Chen JC, Ser KH, Lee YC, Chen SC. Revisional Gastric Bypass for Failed Restrictive Procedures: Comparison of Single-Anastomosis (Mini-) and Roux-en-Y Gastric Bypass. Obes Surg. 2018 Apr;28(4):970-975. doi: 10.1007/s11695-017-2991-0.
- Results publication: 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 28593484Felsenreich DM, Kefurt R, Schermann M, Beckerhinn P, Kristo I, Krebs M, Prager G, Langer FB. Reflux, Sleeve Dilation, and Barrett's Esophagus after Laparoscopic Sleeve Gastrectomy: Long-Term Follow-Up. Obes Surg. 2017 Dec;27(12):3092-3101. doi: 10.1007/s11695-017-2748-9.
- Results publication: PubMed 22027290Weiner RA, Theodoridou S, Weiner S. Failure of laparoscopic sleeve gastrectomy--further procedure? Obes Facts. 2011;4 Suppl 1(Suppl 1):42-6. doi: 10.1159/000327343. Epub 2011 Apr 4.
- Results publication: PubMed 27887931Casillas RA, Um SS, Zelada Getty JL, Sachs S, Kim BB. Revision of primary sleeve gastrectomy to Roux-en-Y gastric bypass: indications and outcomes from a high-volume center. Surg Obes Relat Dis. 2016 Dec;12(10):1817-1825. doi: 10.1016/j.soard.2016.09.038. Epub 2016 Oct 4.
- Results publication: PubMed 24442421Disse E, Pasquer A, Espalieu P, Poncet G, Gouillat C, Robert M. Greater weight loss with the omega loop bypass compared to the Roux-en-Y gastric bypass: a comparative study. Obes Surg. 2014 Jun;24(6):841-6. doi: 10.1007/s11695-014-1180-7.
- Individual participant dataSharing planned: No. Anonymous data will be published.
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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.
Sonja Chiappetta, MD principal investigator
Sana Klinikum Offenbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux en Y gastric bypass and Mini/One anastomosis gastric bypass in people with Obesity, 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 4 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 2 Oct 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?
Weight Loss (time frame: 1 year follow-up). The study lists 2 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 NCT03526783, 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 2 Oct 2018.