An interventional study of Intragastric Balloon (IGB), group A and diet, control group B in Morbid Obesity, sponsored by Hospital Severo Ochoa. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by Hospital Severo Ochoa · Not applicable, Interventional, and Treatment
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.
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)
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 81 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Hospital Severo Ochoa is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the intervention in the group A : was to place a preoperative intragastric balloon (IGB-BIB®) in the stomach for 6 months before surgery plus an hypocaloric diet 1200 Kilocalories (Kcal)
Device: Intragastric Balloon (IGB), group A · Other: diet, control group B
the intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal)
Other: diet, control group B
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
Also known as: BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM
the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
Also known as: 1200 Kilocalories (Kcal) diet
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
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
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
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
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
151 patients were eligibles for the study and were evaluated at the endocrinologist office
| Milestone | Group B | IGB-BIB® Group A |
|---|---|---|
| Started | 42 | 39 |
| Completed | 34 | 32 |
| Not completed | 8 | 7 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Protocol violation | 5 | 2 |
| Withdrew: Withdrawal by subject | 3 | 4 |
postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
| Participants | Group B | IGB Group A |
|---|---|---|
| postsurgical morbidity | 10 | 8 |
| moderate-severe postsurgical morbidity | 8 | 4 |
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 ".
| Participants | Group B | IGB Group A |
|---|---|---|
| intragastric balloon morbidity (complications) | — | 8 |
| severe intragastric balloon morbidity | — | 2 |
| total postsurgical morbidity | 10 | 15 |
all in all hospital stay
| days | Group B | IGB Group A |
|---|---|---|
| Hospital Stay, | 10.3 ± 15.3 | 7 ± 4.3 |
number of patients with surgical conversion from laparoscopic to open surgery
| Participants | Group B | IGB Group A |
|---|---|---|
| Rate of Surgical Conversion to Open Surgery | 1 | 1 |
Percentage of Re-operations during all the period of the study ending within 90 days after surgery
| percentage of participants | Group B | IGB Group A |
|---|---|---|
| Percentage of Re-operations | 11.8 | 6.3 |
Collected over from randomization six months before surgery to 90 days after surgey. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group B | 0/34 (0%) | 2/34 (5.9%) | 8/34 (23.5%) |
| IGB Group A | 0/32 (0%) | 1/32 (3.1%) | 7/32 (21.9%) |
| Event | Group B | IGB Group A |
|---|---|---|
| acute renal failureRenal and urinary disorders | 2/34 | 1/32 |
| Event | Group B | IGB Group A |
|---|---|---|
| surgical wound infectionInfections and infestations | 8/34 | 7/32 |
| Age, Continuous(years OF AGE) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Mean | 42.6 ± 9.2 | 43 ± 10.2 | 42.8 ± 9.6 |
| Sex: Female, Male(Participants) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Female | 24 | 21 | 45 |
| Male | 10 | 11 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Hispanic or Latino | 34 | 32 | 66 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Spain | 34 | 32 | 66 |
| Americam Society of Anestesiologist Physical Status Classification System (ASA) ; ASA score III;(participants) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Number | 11 | 12 | 23 |
| Starting weight (kg)(Kg) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Mean | 125 ± 18.5 | 129.2 ± 19.4 | 127.1 ± 18.9 |
| Starting body mass index (starting BMI)("kg/m^2") | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Mean | 46 ± 4.9 | 46.4 ± 6.9 | 46.2 ± 5.7 |
| Starting body mass index (starting BMI) > 50 ("kg/m^2")(Participants) | Group B | Intragastrc Balloon (IGB) Group A | Total |
|---|---|---|---|
| Count of participants | 8 | 7 | 15 |
10 further baseline measures are reported on the registry.
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Severo Ochoa