Morbid Obesity
Conditions
Keywords
morbid obesity, bioenterics intragastric balloon, bariatric surgery
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. 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.
Detailed description
Treatment with an intragastric balloon (IGB) for morbid obesity is a temporary treatment reached as a second step, when the initial nutritional multidisciplinary approach has failed; however, its value is not clear compared with other conventional medical treatments \], though some authors have stated that IGB achieves higher weight loss than conventional diet treatments (12.2% of the initial weight) \]; and others have positioned IGB as the first valid step in order to achieve weight loss in patients who are adequate for a future gastric bypass surgery. Genco et al (2009) have compared the treatment with IGB only vs. laparoscopic sleeve gastrectomy (LSG), and have found no differences in the amount of weight loss at 6 months, but a reduction in adverse events caused by IGB treatment. One of the potential future indications for the intragastric balloon could be its use as a bridge-treatment until bariatric surgery, not only in order to achieve weight loss before surgery, but also to select the group of patients who might benefit more from derivative surgery, as suggested by some authors or its use in special populations such as super-obese patients . The objective would be to reduce weight before the surgical procedure, in order to improve comorbidities, facilitate the surgical technique, and potentially reduce any surgical complications. It is increasingly frequent in many surgical units to try and achieve weigh loss before bariatric surgery, using intragastric balloons (IGB). However, this therapeutic approach currently presents dubious utility. Our study intends to contribute with our experience in the evaluation of IGB before surgery for achieving weight loss, and its impact on post-surgical morbidity. Bariatric surgery shows an important morbidity and there are not to many randomized prospective studies using intragastric- balloons (IGB-BIB®) to evaluate if getting weight lost really matter on decreasing surgical complications before Bariatric surgery OBJECTIVE: To study the usefulness of preoperative IGB-BIB® grA \[sleeve resection (SR) or gastric bypass (GB)\] to help decrease postsurgical complications. Secondly we try to check the rate of IGB-BIB® failures (a total weight loss less than 10% of the initial weight), and the impact on decreasing hospital stay and rate of surgical reoperations. METHODS: The study was a clinical prospective and randomized essay coming from 2009. Cases (grA) had an IGB during 6 months before surgery vs Controls (grB)
Interventions
the intervention was to place An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM) endoscopically under conscious sedation and was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors (PPI), and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
Sponsors
Study design
Eligibility
Inclusion criteria
1. \- Morbid obesity (BMI ≥ 40 kg/m2 ) with a failed Conventional Medical treatment 2. \- Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity with a failed Conventional Medical treatment 3. \- they should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass
Exclusion criteria
1. \- Slight adherence to previous medical treatments . 2. \- Hiatal hernia more than 3 cms 3. \- Patients with active gastric or duodenal ulcer disease 4. \- Severe esophagitis 5. \- Psychiatric diseases (depression, bulimia etc) 6. \- Associated Severe Systemic Disease not amenable to improve with weight loss 7. \- Patients with Inflammatory bowel diseases 8. \- Patients on anticoagulant treatment or steroids . 9. \- Addiction to Drugs or alcohol 10. \- Past history of gastric surgery ,antireflux surgery or any other type of bariatric surgery 11. \- Patient refusing to be followed 6 months before and after surgery 12. \- Pregnancy or foreseeable pregnancy during the study 13. \- Patients with gastric or esophageal varices 14. \- proton pump inhibitor (PPI) allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical Morbidity on Both Arms of the Study | within the 90 days after surgery | postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one |
| Total Postsurgical Morbidity | during the 6 months having the intragastric balloon and 90 days after surgery | total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of The accordion severity grading system . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay, | the period of the study started when patients were randomizated and finished 90 days after surgery | all in all hospital stay |
| Rate of Surgical Conversion to Open Surgery | during the initial laparoscopic surgery | number of patients with surgical conversion from laparoscopic to open surgery |
| Percentage of Re-operations | during all the period of the study ending within 90 days after surgery | Percentage of Re-operations during all the period of the study ending within 90 days after surgery |
Countries
Spain
Participant flow
Recruitment details
151 patients were eligibles for the study and were evaluated at the endocrinologist office
Pre-assignment details
40 patients rejected to be included in the study and 30 were excluded before randomization for not to fulfill all the established requirement to be included
Participants by arm
| Arm | Count |
|---|---|
| Group B this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations | 34 |
| Intragastrc Balloon (IGB) Group A this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems | 32 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 5 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Age, Continuous | 42.6 years OF AGE STANDARD_DEVIATION 9.2 | 43 years OF AGE STANDARD_DEVIATION 10.2 | 42.8 years OF AGE STANDARD_DEVIATION 9.6 |
| Americam Society of Anestesiologist Physical Status Classification System (ASA) ; ASA score III; | 11 participants | 12 participants | 23 participants |
| BMI before surgery(kg/m^2) | 44.3 kg/m^2 STANDARD_DEVIATION 5.5 | 40 kg/m^2 STANDARD_DEVIATION 6.2 | 42.2 kg/m^2 STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 32 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Excess Body Mass Index Loss (EBMIL) before surgery (excess BMI loss) | 1 percentage of EBMI loss | 6.04 percentage of EBMI loss | 3 percentage of EBMI loss |
| Excess weight loss (EWL) before surgery | 4.54 percentage of EWL | 27.14 percentage of EWL | 11.1 percentage of EWL |
| ICU (hours) intensive care unit | 21.5 hours) | 11 hours) | 20 hours) |
| Operation time (hours) | 2.8 hours STANDARD_DEVIATION 0.73 | 2.8 hours STANDARD_DEVIATION 0.79 | 2.8 hours STANDARD_DEVIATION 0.76 |
| Percentage of Failure of Intragastric Balloon | — | 11 Participants | 11 Participants |
| Region of Enrollment Spain | 34 Participants | 32 Participants | 66 Participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
| Starting body mass index (starting BMI) | 46 kg/m^2 STANDARD_DEVIATION 4.9 | 46.4 kg/m^2 STANDARD_DEVIATION 6.9 | 46.2 kg/m^2 STANDARD_DEVIATION 5.7 |
| Starting body mass index (starting BMI) > 50 (kg/m^2) | 8 Participants | 7 Participants | 15 Participants |
| Starting weight (kg) | 125 Kg STANDARD_DEVIATION 18.5 | 129.2 Kg STANDARD_DEVIATION 19.4 | 127.1 Kg STANDARD_DEVIATION 18.9 |
| Surgery (sleeve resection (LSG)or gastric bypass (LGBP) LGBP | 23 Participants | 23 Participants | 46 Participants |
| Surgery (sleeve resection (LSG)or gastric bypass (LGBP) LSG | 11 Participants | 9 Participants | 20 Participants |
| total body weight loss (TBWL) > 10% | 4 Participants | 18 Participants | 22 Participants |
| Total weight loss (TWL) | 3 Kg | 16 Kg | 7 Kg |
| Weight before surgery (Kg) | 121.3 Kg STANDARD_DEVIATION 20.5 | 112.8 Kg STANDARD_DEVIATION 16.4 | 117.2 Kg STANDARD_DEVIATION 19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 8 / 34 | 7 / 32 |
| serious Total, serious adverse events | 2 / 34 | 1 / 32 |
Outcome results
Postsurgical Morbidity on Both Arms of the Study
postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Time frame: within the 90 days after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group B | Postsurgical Morbidity on Both Arms of the Study | postsurgical morbidity | 10 Participants |
| Group B | Postsurgical Morbidity on Both Arms of the Study | moderate-severe postsurgical morbidity | 8 Participants |
| IGB Group A | Postsurgical Morbidity on Both Arms of the Study | postsurgical morbidity | 8 Participants |
| IGB Group A | Postsurgical Morbidity on Both Arms of the Study | moderate-severe postsurgical morbidity | 4 Participants |
Total Postsurgical Morbidity
total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of The accordion severity grading system .
Time frame: during the 6 months having the intragastric balloon and 90 days after surgery
Population: Group B did not receive an intra-gastric balloon, and was thus not evaluated for balloon related complications.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group B | Total Postsurgical Morbidity | total postsurgical morbidity | 10 Participants |
| IGB Group A | Total Postsurgical Morbidity | intragastric balloon morbidity (complications) | 8 Participants |
| IGB Group A | Total Postsurgical Morbidity | severe intragastric balloon morbidity | 2 Participants |
| IGB Group A | Total Postsurgical Morbidity | total postsurgical morbidity | 15 Participants |
Hospital Stay,
all in all hospital stay
Time frame: the period of the study started when patients were randomizated and finished 90 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group B | Hospital Stay, | 10.3 days | Standard Deviation 15.3 |
| IGB Group A | Hospital Stay, | 7 days | Standard Deviation 4.3 |
Percentage of Re-operations
Percentage of Re-operations during all the period of the study ending within 90 days after surgery
Time frame: during all the period of the study ending within 90 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group B | Percentage of Re-operations | 11.8 percentage of participants |
| IGB Group A | Percentage of Re-operations | 6.3 percentage of participants |
Rate of Surgical Conversion to Open Surgery
number of patients with surgical conversion from laparoscopic to open surgery
Time frame: during the initial laparoscopic surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group B | Rate of Surgical Conversion to Open Surgery | 1 Participants |
| IGB Group A | Rate of Surgical Conversion to Open Surgery | 1 Participants |