NCT00793728

Brief Summary

This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

6.8 years

First QC Date

November 18, 2008

Last Update Submit

August 19, 2015

Conditions

Morbid Obesity

Keywords

Morbid obesityHigh risk

Outcome Measures

Primary Outcomes (3)

  • Weight lose

    One year

  • Food tolerance

    One year

  • Quality of life

    One year

Secondary Outcomes (1)

  • Metabolic syndrome outcome

    One year

Study Arms (2)

Antrectomy

ACTIVE COMPARATOR
Procedure: Sleeve gastrectomy

Without antrectomy

ACTIVE COMPARATOR
Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomyPROCEDURE

Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach

AntrectomyWithout antrectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\>40 kg/m2
  • Age \>18 years old
  • Eligible for laparoscopic surgery

You may not qualify if:

  • Prior bariatric surgery
  • Sleeve gastrectomy as a part of a duodenal switch
  • Second time surgery before 18 months
  • Other procedures done during the surgery
  • Conversion to laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amador Garcia Ruiz de Gordejuela, Consultant

    Consultant of Surgery

    PRINCIPAL INVESTIGATOR

  • Jordi Pujol Gebelli, Consultant

    Consultant of Surgery

    PRINCIPAL INVESTIGATOR

  • Carles Masdevall Noguera, Consultant

    Consultant of Surgery

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 19, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

ES(1)