NCT02601092

Brief Summary

Several retrospective studies have shown same efficiency in regard to weight loss, with a lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial is to compare the two procedures in respect of excess weight loss, complications, operation time, length of stay and the metabolic impact on the hormonal brain-gut-axis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

September 28, 2015

Last Update Submit

February 23, 2017

Conditions

ObesityBypass Complications

Keywords

Mini Gastric BypassRoux-en-Y Gastric BypassRCT

Outcome Measures

Primary Outcomes (1)

  • Excess Weight Loss

    1 year postoperative

Secondary Outcomes (10)

  • Early surgical complications

    ≤ 30 days

  • Early non-surgical complications

    ≤ 30 days

  • Operation time

    intraoperative

  • Length of stay

    up to 24 weeks

  • Subjective perception of the appetite and saturation

    6 weeks, 1 and 3 years

  • +5 more secondary outcomes

Study Arms (2)

Mini Gastric Bypass

EXPERIMENTAL

The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine. No drugs or devices will be used.

Procedure: Mini Gastric Bypass

Roux-en-Y Gastric Bypass

ACTIVE COMPARATOR

This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients. No drugs or devices will be used.

Procedure: Roux-en-Y Gastric Bypass

Interventions

Mini Gastric BypassPROCEDURE

The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine. No drugs or devices will be used.

Mini Gastric Bypass
Roux-en-Y Gastric BypassPROCEDURE

This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a "Roux limb". In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients. No drugs or devices will be used.

Roux-en-Y Gastric Bypass

Eligibility Criteria

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

You may qualify if:

  • BMI \> 35
  • age \> 18

You may not qualify if:

  • malignancy
  • lack of compliance
  • BMI \> 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

RECRUITING

Related Publications (12)

  • Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

    PMID: 17715408RESULT

  • Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.

    PMID: 17715409RESULT

  • Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.

    PMID: 25105982RESULT

  • Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.

    PMID: 11433900RESULT

  • Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.

    PMID: 15973097RESULT

  • Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.

    PMID: 16259892RESULT

  • Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.

    PMID: 23011462RESULT

  • Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3-60 month follow-up. Obes Surg. 2000 Jun;10(3):233-9. doi: 10.1381/096089200321643511.

    PMID: 10929154RESULT

  • Rutledge R. Similarity of Magenstrasse-and-Mill and Mini-Gastric bypass. Obes Surg. 2003 Apr;13(2):318. doi: 10.1381/096089203764467315. No abstract available.

    PMID: 12740148RESULT

  • Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.

    PMID: 17060766RESULT

  • Delko T, Kraljevic M, Lazaridis II, Kostler T, Jomard A, Taheri A, Lutz TA, Osto E, Zingg U. Laparoscopic Roux-Y-gastric bypass versus laparoscopic one-anastomosis gastric bypass for obesity: clinical & metabolic results of a prospective randomized controlled trial. Surg Endosc. 2024 Jul;38(7):3875-3886. doi: 10.1007/s00464-024-10907-7. Epub 2024 Jun 3.

    PMID: 38831218DERIVED

  • Kraljevic M, Delko T, Kostler T, Osto E, Lutz T, Thommen S, Droeser RA, Rothwell L, Oertli D, Zingg U. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial. Trials. 2017 May 22;18(1):226. doi: 10.1186/s13063-017-1957-9.

    PMID: 28532499DERIVED

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

  • Urs Zingg, MD

    Spital Limmattal Schlieren

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marko Kraljevic, MD

CONTACT

+41 79 942 50 10marko.kraljevic@gmail.com

Tarik Delko, MD

CONTACT

+41 78 910 30 21tarik.delko@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 28, 2015

First Posted

November 10, 2015

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2020

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

CH(1)