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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
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\". The intervention in this group was was to place an intragastric Balloon for 6 months vs a control group \"B\" with the same type of surgical procedures but without preoperative IGB-BIB.The intervention on this group was only to treat the obesity only with diet for 6 months . 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.
Epistemonikos ID: 440d306b8bb63eb7ec02bdbd5b0a07d71cd08cb7
First added on: May 11, 2024