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Completed

NCT Number: NCT00722995

Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine

Saint-Denis, 93205, France

About this study

In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 >= BMI <= 50), a super obesity (BMI >50), a super super obesity (BMI>60), and obese patients (BMI>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.

This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged from 18 to 60 years old
  • Patient having given his consent to the use of data from the project
  • Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)
  • Patient presenting one of the following criteria:
  • A morbid obesity strict with BMI> 40
  • A super obesity BMI> 50
  • A super super obesity BMI> 60
  • Obese patient in failure following the installation of a gastric banding with BMI> 35
  • obese patient 35>BMI>40 with a comorbidity
  • Preliminary agreement during the consultation of a psychiatrist / psychologist

Exclusion criteria

  • Patient with complications or co morbidities associated involving life to less 6 months
  • Patient presenting no anaesthetic indication
  • Patient presenting no psychiatric indication for obesity surgery
  • Patient not affiliated with a social security scheme
  • Pregnant Patient likely to breastfeed in the first year

Treatment and study plan

Sleeve gastrectomy

Procedure

Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity

Other names: SLEEVE

Gastric bypass

Procedure

Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Other names: BYPASS

Primary outcomes

  1. Composite criteria of morbid/mortality

    Time frame: during 18 months and 36 months

Secondary outcomes

  1. Frequency of morbid events

    Time frame: during the follow up

  2. Percentage of excess weight loss

    Time frame: during 18 and 36 months

  3. Frequency of patients having a excess weight loss superior than 50%

    Time frame: during 36 months

  4. Regression of morbidities

    Time frame: during 36 months

  5. Rate serum ghrelin

    Time frame: at inclusion visit, 6, 12, 18 and 36 months

  6. Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score

    Time frame: at inclusion visit, 6, 12, 18 and 36 months

  7. Frequency of morbid/mortality events

    Time frame: during 36 months

  8. Frequency of patients having excess weight loss superior than 50%

    Time frame: during 18 month

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.

Acronym: SLEEVE

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2008
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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