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

NCT02144545 | Unknown DMC

• 1 other identifier: IIBSP-RES-2012-178
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Keywords

Surgery; Morbid Obesity; Bariatric surgery; Sleeve gastrectomy; Bougie Size; Distance from pylorus; Hormones; Gastric remanent

Outcome Measures

Primary Outcomes (2)

• Body mass index

  1 year

• Gastric volume

  1 month and 1 year

Secondary Outcomes (3)

• Gastric emptying time

  1 year

• Lower esophageal sphincter pressure

  1 year

• Number of gastroesophageal reflux episodes

  1 year

Other Outcomes (1)

• Hormone levels

  1 year

Study Arms (4)

Bougie Size 33Fr Distance pylorus 2 cm

EXPERIMENTAL

Sleeve gastrectomy with a 33Fr bougie size and 2 cm distance from the pylorus.

Procedure: Bougie Size 33 Fr; Procedure: Distance pylorus 2 cm

Bougie Size 33Fr Distance pylorus 5 cm

EXPERIMENTAL

Sleeve gastrectomy with a 33Fr bougie size and 5 cm distance from the pylorus

Procedure: Bougie Size 33 Fr; Procedure: Distance pylorus 5 cm

Bougie Size 42Fr Distance pylorus 2 cm

EXPERIMENTAL

Sleeve gastrectomy with a 42Fr bougie size and 2 cm distance from the pylorus

Procedure: Bougie Size 42 Fr; Procedure: Distance pylorus 2 cm

Bougie Size 42Fr Distance pylorus 5 cm

EXPERIMENTAL

Sleeve gastrectomy with a 42Fr bougie size and 2 cm distance from the pylorus

Procedure: Bougie Size 42 Fr; Procedure: Distance pylorus 5 cm

Interventions

Bougie Size 33 Fr PROCEDURE

Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Bougie Size 33Fr Distance pylorus 2 cm; Bougie Size 33Fr Distance pylorus 5 cm

Bougie Size 42 Fr PROCEDURE

Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Bougie Size 42Fr Distance pylorus 2 cm; Bougie Size 42Fr Distance pylorus 5 cm

Distance pylorus 2 cm PROCEDURE

Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Bougie Size 33Fr Distance pylorus 2 cm; Bougie Size 42Fr Distance pylorus 2 cm

Distance pylorus 5 cm PROCEDURE

Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy

Bougie Size 33Fr Distance pylorus 5 cm; Bougie Size 42Fr Distance pylorus 5 cm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Carmen Balagué Ponz, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Carmen Balagué Ponz, MD

CONTACT

+34 935565671; cbalague@santpau.cat

Eduardo Maria Targarona Soler, MD PhD

CONTACT

+34 935565671; etargarona@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: May 22, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

ES (1)