MGB/OAGB Versus RYGB After Failed Sleeve

NCT ID: NCT03526783

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Failed sleeve gastrectomy - RNYGB

Intervention: Roux en Y gasric bypass (RNYGB)

Group Type OTHER

Roux en Y gastric bypass

Intervention Type PROCEDURE

Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)

Failed sleeve gastrectomy - MGB/OAGB

Inervention: Mini/One anastomosis gasic bypass (MGB/OAGB)

Group Type OTHER

Mini/One anastomosis gastric bypass

Intervention Type PROCEDURE

Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)

Interventions

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Roux en Y gastric bypass

Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)

Intervention Type PROCEDURE

Mini/One anastomosis gastric bypass

Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)

Intervention Type PROCEDURE

Other Intervention Names

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RNYGB MGB/OAGB

Eligibility Criteria

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Inclusion Criteria

Patients with failed sleeve due to

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sana Klinikum Offenbach

OTHER

Sponsor Role lead

Responsible Party

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Sonja Chiappetta, MD

MD, Senior Consultant, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sonja Chiappetta, MD

Role: PRINCIPAL_INVESTIGATOR

Sana Klinikum Offenbach

Locations

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Sana Klinikum Offenbach

Offenbach, Offenbach Am Main, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 29101719 (View on PubMed)

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.

Reference Type RESULT
PMID: 21890430 (View on PubMed)

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.

Reference Type RESULT
PMID: 28593484 (View on PubMed)

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.

Reference Type RESULT
PMID: 22027290 (View on PubMed)

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.

Reference Type RESULT
PMID: 27887931 (View on PubMed)

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.

Reference Type RESULT
PMID: 24442421 (View on PubMed)

Other Identifiers

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FF 3/2018

Identifier Type: -

Identifier Source: org_study_id

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