Clinical Trial: Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity

Brief Summary:

Introduction: bariatric surgery shows an important morbidity and there are some reports that have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.

Patients Methods: Since 2009 we are performing a randomized and prospective study to assess the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric bypass (GB)] "group A" vs a control group "B" with the same type of surgical procedures but without preoperative IGB-BIB. All patients coming for both groups were followed at 4-week intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least 30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB failure.Intragastric balloon failure was considered when the weight loss is less than 10% from the initial weight. We defined severe complication whenever the patient had to be admitted in the hospital after discharge, new surgeries or transfusions were required or the hospital stay was longer than 7-10 days.


Detailed Summary:
Sponsor: Hospital Severo Ochoa

Current Primary Outcome: morbidity and mortality on both arms of the study [ Time Frame: within the 90 days after surgery ]

we checked total morbidity and mortality which included Intragastric balloon related morbidity ,postsurgical morbidity and mortality


Original Primary Outcome: morbidity rate [ Time Frame: wihtin the 90 days after surgery ]

we checked total morbidity which included Intragastric balloon related morbidity ,postsurgical morbidity and mortality


Current Secondary Outcome:

  • hospital stay, [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay
  • factors associated with surgical morbidity [ Time Frame: during the preoperative period of the study and within the 90 days after surgery ]
    multivariate regression analysis to assess the factors related with morbidity (weight before surgery, age,type of surgery?)
  • rate or surgical conversion to open surgery [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay
  • rate of reoperations [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay


Original Secondary Outcome:

  • hospital stay [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay
  • factors associated with surgical morbidity [ Time Frame: during the preoperative period of the study and within the 90 days after surgery ]
    multivariate regression analysis to assess the factors related with morbidity (weight before surgery, age,type of surgery?)


Information By: Hospital Severo Ochoa

Dates:
Date Received: November 19, 2013
Date Started: January 2009
Date Completion: December 2016
Last Updated: August 15, 2016
Last Verified: August 2016