Clinical trial NCT03526783: MGB/OAGB Versus RYGB After Failed Sleeve
Official title: A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity Surgery
Failed Sleeve Gastrectomy
Roux-en-Y gastric bypass
Mini/One anastomosis gastric bypass
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Patients with failed sleeve due to

* weight regain
* weight loss failure
* gastro-esophageal reflux disease Grade B

Exclusion Criteria:

-

Primary outcomes:
measure: Weight Loss
timeFrame: 1 year follow-up
measure: Weight Loss
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Perioperative Complications
timeFrame: up to 30 days postsurgery
measure: Postoperative Morbidity
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
state: Offenbach Am Main
Study officials:
affiliation: Sana Klinikum Offenbach
name: Sonja Chiappetta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Felsenreich 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.
citation: Weiner 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.
citation: Casillas 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.
citation: Disse 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.