NCT02779322

Brief Summary

This study try to identify differences in cost, length of operation and results between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish public health system hospital. The patients of the trial will have the preoperative studies, hospital treatment during the admission, postoperative treatment and follow up as any other patient included in the hospital bariatric surgery program. No new methods are applied other than randomly choose the surgical technique. Patients will be randomized in a 1:1 ratio to each group.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

June 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

4.4 years

First QC Date

May 16, 2016

Last Update Submit

April 18, 2020

Conditions

Morbid ObesityPostoperative ComplicationsWeight Loss

Keywords

gastric bypasshospital chargesmini gastric bypass

Outcome Measures

Primary Outcomes (2)

  • Hospital Cost in euros

    Total hospital expenses during admission for the surgery

    up to 3 months

  • Length of operation in minutes

    Duration of the surgical procedure

    1 day

Secondary Outcomes (9)

  • weight loss in kilograms

    3 months

  • weight loss in kilograms

    6 months

  • weight loss in kilograms

    9 months

  • weight loss in kilograms

    12 months

  • weight loss in kilograms

    18 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    through study completion an average of 5 year

Study Arms (2)

Minigastric bypass

ACTIVE COMPARATOR

Intervention(s): The patient will have done a Laparoscopic one anastomosis gastric bypass (minigastric bypass) at the time of the surgical procedure.

Procedure: Minigastric bypass

Gastric bypass

ACTIVE COMPARATOR

The patient will have a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure

Procedure: Gastric bypass

Interventions

Minigastric bypassPROCEDURE

The patient will be submitted to a minigastric bypass at the time of the operation

Also known as: Single or One anastomosis gastric bypass
Minigastric bypass
Gastric bypassPROCEDURE

In this case a simplified conventional gastric bypass will be performed

Also known as: Laparoscopic gastric bypass
Gastric bypass

Eligibility Criteria

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

You may qualify if:

  • criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
  • age between 18-65 years-old.
  • BMI between 40-50 kg/m2
  • Obesity for more than 5 years of evolution
  • Fail in medical supervised weight loss program
  • patient knowing of the mechanism of weight loss after surgery and agreement to collaborate with medical recommendations, diet, medical treatment, as well as the visit established in the follow up program
  • patient accepting that surgery objective is not to achieve the ideal weight.
  • signed specific informed consent
  • women will agree in avoid gestation during one year after surgery

You may not qualify if:

  • Patients unable to sign the informed consent form because of a mental disorder.
  • endocrine diseases causing obesity
  • unstable mental disorder, evaluated for a psychiatry MD.
  • high anesthetic risk making surgery too risky.
  • Malignant neoplasm
  • Gastroesophageal reflux disease (GERD) with endoscopic esophagitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de CirugĂ­a General. Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (6)

  • 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: 23011462BACKGROUND

  • 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: 11433900BACKGROUND

  • 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: 15973097BACKGROUND

  • Lee WJ, Lin YH. Single-anastomosis gastric bypass (SAGB): appraisal of clinical evidence. Obes Surg. 2014 Oct;24(10):1749-56. doi: 10.1007/s11695-014-1369-9.

    PMID: 25056233BACKGROUND

  • Piche ME, Auclair A, Harvey J, Marceau S, Poirier P. How to choose and use bariatric surgery in 2015. Can J Cardiol. 2015 Feb;31(2):153-66. doi: 10.1016/j.cjca.2014.12.014. Epub 2014 Dec 15.

    PMID: 25661550BACKGROUND

  • Ramos AC, Silva AC, Ramos MG, Canseco EG, Galvao-Neto Mdos P, Menezes Mde A, Galvao TD, Bastos EL. Simplified gastric bypass: 13 years of experience and 12,000 patients operated. Arq Bras Cir Dig. 2014;27 Suppl 1(Suppl 1):2-8. doi: 10.1590/s0102-6720201400s100002.

    PMID: 25409956BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidPostoperative ComplicationsWeight Loss

Interventions

Single PersonGastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBody Weight Changes

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic FactorsBariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Miguel J Garcia-Oria, MD PhD FACS

    Unidad Cirugia Obesidad y Metabolica Hospital Puerta de Hierro

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 20, 2016

Study Start

June 1, 2015

Primary Completion

November 1, 2019

Study Completion

June 1, 2025

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

The plan is to publish the results of our study in a scientific journal when it be completed, not to publish the individual patient data, just the global data comparing both groups of study.

Locations

ES(1)