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Impact of Size of Gastric Sleeve on the Weight Loss. Correlation With Gastric Function and Endocrine-metabolic Changes.

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ClinicalTrials.gov Identifier: NCT02144545
Recruitment Status : Unknown
Verified September 2015 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : May 22, 2014
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:

Morbid Obesity (MO) is considered the most important epidemic in the developed world in the twenty-first century. After initial assessment of morbidly obese patients and the exclusion of potentially correctable causes, management involves a combination of dietary changes, cognitive therapy, physical activity, psychological support and pharmacological treatment. However, any combination of these factors has proven long-term effectiveness in achieving significant and sustained reduction of excess weight. Currently, surgery is the only treatment capable of achieving this goal, interacting also with significant improvement in quality of life and overall long-term mortality.

In recent years, several authors have reported excellent short-term results with performing sleeve gastrectomy, but whether some aspects regarding the variability of gastric tubulization design could influence the results obtained in relation to weight loss and functional changes and gastric hormones.

The main objective of this study is to assess the size of the gastric tubulization (based probe calibration and the distance from the pylorus to which initiate gastric section) that can provide a better clinical outcome (such as excess weight loss) in patients undergoing surgery for morbid obesity. Secondary objectives were to assess the morphological changes, physiological and hormonal obtained according to the size of the gastric tubulization and its effect on weight loss patients.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: Bougie Size 33 Fr Procedure: Bougie Size 42 Fr Procedure: Distance pylorus 2 cm Procedure: Distance pylorus 5 cm Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Impact of the Size of Gastric Sleeve o the Weight Loss in Patients Submitted to Bariatric Surgery. Evaluation of Changes in Gastric Motility and Endocrine-metabolic Function.
Study Start Date : October 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bougie Size 33Fr Distance pylorus 2 cm
Sleeve gastrectomy with a 33Fr bougie size and 2 cm distance from the pylorus.
Procedure: Bougie Size 33 Fr
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Procedure: Distance pylorus 2 cm
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Experimental: Bougie Size 33Fr Distance pylorus 5 cm
Sleeve gastrectomy with a 33Fr bougie size and 5 cm distance from the pylorus
Procedure: Bougie Size 33 Fr
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Procedure: Distance pylorus 5 cm
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Experimental: Bougie Size 42Fr Distance pylorus 2 cm
Sleeve gastrectomy with a 42Fr bougie size and 2 cm distance from the pylorus
Procedure: Bougie Size 42 Fr
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Procedure: Distance pylorus 2 cm
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Experimental: Bougie Size 42Fr Distance pylorus 5 cm
Sleeve gastrectomy with a 42Fr bougie size and 2 cm distance from the pylorus
Procedure: Bougie Size 42 Fr
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Procedure: Distance pylorus 5 cm
Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy




Primary Outcome Measures :
  1. Body mass index [ Time Frame: 1 year ]
  2. Gastric volume [ Time Frame: 1 month and 1 year ]

Secondary Outcome Measures :
  1. Gastric emptying time [ Time Frame: 1 year ]
  2. Lower esophageal sphincter pressure [ Time Frame: 1 year ]
  3. Number of gastroesophageal reflux episodes [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Hormone levels [ Time Frame: 1 year ]
    Insulin, Glucagon, glucagon-like peptide (GLP-1), gastric inhibitory peptide (GIP), Ghrelin, Leptin, Adiponectin, Peptide YY



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than 18 years and less than 65 years
  • BMI more than 40 kg/m2 or more than 35 kg/m2 with comorbidities likely to improve after weight loss.
  • Morbid obesity established at least five years.
  • Continued failures to adequately supervised conservative treatments
  • Absence of endocrine disorders that are due to morbid obesity.
  • Psychological stability:

    • No alcohol or drug abuse.
    • Absence of major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa).
  • Ability to understand the mechanisms to lose weight with surgery and understand that not always achieved good results.
  • Understand that the goal of surgery is to achieve the ideal weight.
  • Commitment for Adherence to surveillance guidelines after surgery
  • Informed consent after receiving all the necessary information (oral and written).
  • Women of childbearing age should avoid pregnancy for at least the first year after surgery

Exclusion Criteria:

  • No acceptance
  • Age less than 18 years or more than 65 years
  • Previous bariatric surgery
  • Previous gastric surgery
  • Inflammatory bowel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144545


Contacts
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Contact: Maria Carmen Balagué Ponz, MD +34 935565671 cbalague@santpau.cat
Contact: Eduardo Maria Targarona Soler, MD PhD +34 935565671 etargarona@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Maria Carmen Balagué Ponz, MD    +34 93 556 56 71    cbalague@santpau.cat   
Contact: Eduardo Maria Targarona Soler, MD PhD    +34 93 556 56 71    etargarona@santpau.cat   
Sub-Investigator: Eduardo Maria Targarona Soler, MD PhD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Maria Carmen Balagué Ponz, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02144545     History of Changes
Other Study ID Numbers: IIBSP-RES-2012-178
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Surgery
Morbid Obesity
Bariatric surgery
Sleeve gastrectomy
Bougie Size
Distance from pylorus
Hormones
Gastric remanent
Additional relevant MeSH terms:
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Obesity, Morbid
Weight Loss
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes