MGB/OAGB Versus RYGB After Failed Sleeve

Obesity Clinical Trial

Official title:

A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526783
• Other study ID #: FF 3/2018
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: Sana Klinikum Offenbach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Patients with failed sleeve due to

• weight regain

• weight loss failure

• gastro-esophageal reflux disease Grade B

Exclusion Criteria:

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Roux en Y gastric bypass
Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)
• Mini/One anastomosis gastric bypass
Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)

Locations

Country	Name	City	State
Germany	Sana Klinikum Offenbach	Offenbach	Offenbach Am Main

Sponsors (1)

Lead Sponsor	Collaborator
Sana Klinikum Offenbach

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View 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. — View 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/s1 — View 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. — View Citation

Weiner RA, Theodoridou S, Weiner S. Failure of laparoscopic sleeve gastrectomy--further procedure? Obes Facts. 2011;4 Suppl 1:42-6. doi: 10.1159/000327343. Epub 2011 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Total Body Weight Loss in %	1 year follow-up
Primary	Weight Loss	Excess Weight Loss in %	1 year follow-up
Secondary	Perioperative Complications	Perioperative Complications (Clavin-Dindo)	up to 30 days postsurgery
Secondary	Postoperative Morbidity	Postoperative Morbidity	1 year follow-up