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Assessment of Nutritional Consequences of Sleeve Gastrectomy (ERNEST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand Identifier:
First received: April 18, 2011
Last updated: November 17, 2011
Last verified: November 2011

Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two types of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a purely restrictive reversible procedure, and gastric bypass (GBP), an irreversible procedure, which associates restriction and mild malabsorption. Longitudinal sleeve gastrectomy (LSG) is another bariatric procedure which tends to develop quickly. More recent, this technique is recognized in France by the High Authority of Health since 2008, consisting of fundus and greater curvature resection, removing 75 % the gastric volume, leaving a narrow gastric tube or "sleeve".

Although malabsorption does not occur in most bariatric procedures, micronutrient deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have minor effects on normal physiological digestive processes but could lead to vitamin deficiency secondary to decreased nutrient intake and a tendency towards avoidance of certain types of food due to intolerance. Studies of nutritional complications of bariatric surgery concern essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no longer performed in France. The nutritional impact of LSG remains to be evaluated. To date, data concerning evaluation of nutritional status from patients who underwent LSG are almost non-existent. Considering this type of surgical procedure, the investigators expect to observe essentially a deficiency in vitamin B12 and iron. Indeed, defined as a purely restrictive intervention, LSG consists of gastric fundus resection which is the site of intrinsic factor production, itself necessary for vitamin B12 absorption. Moreover, decrease of hydrochloric acid production and potential vomiting caused by gastric resection can alter iron absorption.

In view of the increasing popularity of this surgical technique, assessment of the nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.

Condition Intervention
Procedure: Longitudinal sleeve gastrectomy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Nutritional Consequences of Sleeve Gastrectomy

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • micro nutritional status of patients undergoing sleeve gastrectomy [ Time Frame: at 3, 6, 12, 18 and 24 months after intervention ]

Secondary Outcome Measures:
  • physical composition measured by impedancemetry [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  • arterial blood pressure [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  • HOMA test [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  • lipid assessment [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  • arthropathy estimated clinically [ Time Frame: at 3, 6, 12, 18 and 24 months ]
  • questionnaire SF-36 [ Time Frame: at 6 months after the operation ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
sleeve gastrectomy Procedure: Longitudinal sleeve gastrectomy
The main objective of this study is to assess during a 2-year prospective follow-up, the prevalence of nutrient deficiencies in patients undergoing a longitudinal sleeve gastrectomy for morbid obesity

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
defined population

Inclusion Criteria:

  • Age between 18 and 65 years
  • Initial BMI = 35
  • Proposition of a sleeve gastrectomy during a multidisciplinary consultation
  • Bariatric surgery procedure carried out at the University Hospital of Clermont- Ferrand.
  • Patient covered by the national health insurance scheme
  • Patient having read, understood and signed the information sheet and the consent form

Exclusion Criteria:

  • History of pathology or major surgical procedure which could interfere with the nutritional state and other study parameters (cancer, DID, digestive pathology, infectious or inflammatory disease)
  • Pregnant or breast-feeding women
  • Existence of cognitive disorders which could interfere with compliance of the study
  • Person deprived of judicial or administrative freedom
  • Participation in another study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01475903

Contact: Patrick LACARIN 04 73 75 11 95

CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Julie LEGER-GUIST'HAU, MD University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01475903     History of Changes
Other Study ID Numbers: CHU-0093
Study First Received: April 18, 2011
Last Updated: November 17, 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Sleeve gastrectomy
Nutritional impact
Vitamin deficiency processed this record on April 28, 2017