N/A
N=81
Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01998243 ↗Enrolled (actual)
81
Serious AEs
4.6%
Results posted
Jun 2019
Primary outcome: Primary: Postsurgical Morbidity on Both Arms of the Study — 10; 8; 8; 4 Participants — p=0.689
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intragastric Balloon (IGB), group A (Device); diet, control group B (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Severo Ochoa
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postsurgical Morbidity on Both Arms of the Study |
10; 8; 8; 4 | 0.689 |
| PRIMARY Total Postsurgical Morbidity |
8; 2; 10; 15 | 0.144 |
| SECONDARY Hospital Stay, |
10.3; 7 | 0.937 |
| SECONDARY Rate of Surgical Conversion to Open Surgery |
1; 1 | 1 |
| SECONDARY Percentage of Re-operations |
11.8; 6.3 | 0.673 |
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". 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.
Eligibility Criteria
Inclusion Criteria
- - Morbid obesity (BMI ≥ 40 kg/m2 ) with a failed Conventional Medical treatment
- - Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity with a failed Conventional Medical treatment
- - they should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass
Exclusion Criteria
- - Slight adherence to previous medical treatments .
- - Hiatal hernia more than 3 cms
- - Patients with active gastric or duodenal ulcer disease
- - Severe esophagitis
- - Psychiatric diseases (depression, bulimia etc)
- - Associated Severe Systemic Disease not amenable to improve with weight loss
- - Patients with Inflammatory bowel diseases
- - Patients on anticoagulant treatment or steroids .
- - Addiction to Drugs or alcohol
- - Past history of gastric surgery ,antireflux surgery or any other type of bariatric surgery
- - Patient refusing to be followed 6 months before and after surgery
- - Pregnancy or foreseeable pregnancy during the study
- - Patients with gastric or esophageal varices
- - proton pump inhibitor (PPI) allergy
Data sourced from ClinicalTrials.gov (NCT01998243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.