NCT03526783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

3.2 years

First QC Date

April 23, 2018

Last Update Submit

September 29, 2018

Conditions

Obesity

Keywords

Obesity SurgeryFailed Sleeve GastrectomyRoux-en-Y gastric bypassMini/One anastomosis gastric bypass

Outcome Measures

Primary Outcomes (2)

  • Weight Loss

    Total Body Weight Loss in %

    1 year follow-up

  • Weight Loss

    Excess Weight Loss in %

    1 year follow-up

Secondary Outcomes (2)

  • Perioperative Complications

    up to 30 days postsurgery

  • Postoperative Morbidity

    1 year follow-up

Study Arms (2)

Failed sleeve gastrectomy - RNYGB

OTHER

Intervention: Roux en Y gasric bypass (RNYGB)

Procedure: Roux en Y gastric bypass

Failed sleeve gastrectomy - MGB/OAGB

OTHER

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

Procedure: Mini/One anastomosis gastric bypass

Interventions

Roux en Y gastric bypassPROCEDURE

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

Also known as: RNYGB
Failed sleeve gastrectomy - RNYGB
Mini/One anastomosis gastric bypassPROCEDURE

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

Also known as: MGB/OAGB
Failed sleeve gastrectomy - MGB/OAGB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with failed sleeve due to
  • weight regain
  • weight loss failure
  • gastro-esophageal reflux disease Grade B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, Offenbach Am Main, 63069, Germany

Location

Related 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.

    PMID: 29101719RESULT

  • 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.

    PMID: 21890430RESULT

  • 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.

    PMID: 28593484RESULT

  • 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.

    PMID: 22027290RESULT

  • 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.

    PMID: 27887931RESULT

  • 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.

    PMID: 24442421RESULT

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Sonja Chiappetta, MD

    Sana Klinikum Offenbach

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Senior Consultant, Principal Investigator

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 16, 2018

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Anonymous data will be published.

Locations

DE(1)