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| ID | Type | Description | Link |
|---|---|---|---|
| FIS PI070682 | Other Grant/Funding Number | SPANISH NATIONAL HEALTH SYSTEM, LAIN ENTRALGO AGENCY |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Introduction: bariatric surgery shows an important morbidity and there are some reports that have used preoperative intragastric-balloons (IGB-BIBĀ®) to decrease surgical morbidity.
Patients Methods: Since 2009 we are performing a randomized and prospective study to assess the usefulness of (IGB-BIBĀ®) 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 Ā® 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-BIBĀ®) to evaluate if getting weight lost really matter on decreasing surgical complications before Bariatric surgery OBJECTIVE: To study the usefulness of preoperative IGB-BIBĀ® "grA" [sleeve resection (SR) or gastric bypass (GB)] to help decrease postsurgical complications. Secondly we try to check the rate of IGB-BIBĀ® 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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGB group A | Experimental | the intervention in the group A : was to place a preoperative intragastric balloon (IGB-BIBĀ®) in the stomach for 6 months before surgery plus an hypocaloric diet 1200 Kilocalories (Kcal) |
|
| control group B | Placebo Comparator | the intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intragastric Balloon (IGB), group A | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 ". | during the 6 months having the intragastric balloon and 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Stay, | all in all hospital stay | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis R RƔbago, MD,PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Department ,Severo Ochoa Hospital | LeganƩs | Madrid | 28911 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11433910 | Background | Hodson RM, Zacharoulis D, Goutzamani E, Slee P, Wood S, Wedgwood KR. Management of obesity with the new intragastric balloon. Obes Surg. 2001 Jun;11(3):327-9. doi: 10.1381/096089201321336692. | |
| 11433911 | Background | Loffredo A, Cappuccio M, De Luca M, de Werra C, Galloro G, Naddeo M, Forestieri P. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001 Jun;11(3):330-3. doi: 10.1381/096089201321336700. |
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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
151 patients were eligibles for the study and were evaluated at the endocrinologist office
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| ID | Title | Description |
|---|---|---|
| FG000 | Group B | 42 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations |
| FG001 | IGB-BIBĀ® Group A | 39 patients included have a preoperative intragastric balloon during a period of 6 months before operation preoperative intragastric balloon ( IGB-BIBĀ®): 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Intragastrc Balloon (IGB) Group A |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | within the 90 days after surgery |
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from randomization six months before surgery to 90 days after surgey
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group B | 34 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute renal failure | Renal and urinary disorders | Systematic Assessment | peritonitis, sepsis, suture dehiscence, respiratory failure, eventration intraperitoneal postoperative bleeding |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgical wound infection | Infections and infestations | Systematic Assessment | mild surgical wound infection ,mild respiratory failure ,eventration, intra abdominal abscess, urinary tract infection, bleeding, haematoma,pneumonia |
we could not reach the number of scheduled patients in the study, due to the number of postrandomization excluded patients; the number of superobese is too short in order to get conclusion in this small group of patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Luis Ramon Rabago Torre | Hospital severo ochoa | 34914818000 | 8326 | lrabagot@gmail.com |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004032 | Diet |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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|
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| diet, control group B | Other | the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet |
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| 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 | during all the period of the study ending within 90 days after surgery |
| 12194556 | Background | Doldi SB, Micheletto G, Perrini MN, Librenti MC, Rella S. Treatment of morbid obesity with intragastric balloon in association with diet. Obes Surg. 2002 Aug;12(4):583-7. doi: 10.1381/096089202762252398. |
| 15186637 | Background | Busetto L, Segato G, De Luca M, Bortolozzi E, MacCari T, Magon A, Inelmen EM, Favretti F, Enzi G. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg. 2004 May;14(5):671-6. doi: 10.1381/096089204323093471. |
| 15329191 | Background | Sallet JA, Marchesini JB, Paiva DS, Komoto K, Pizani CE, Ribeiro ML, Miguel P, Ferraz AM, Sallet PC. Brazilian multicenter study of the intragastric balloon. Obes Surg. 2004 Aug;14(7):991-8. doi: 10.1381/0960892041719671. |
| 16469215 | Background | Alfalah H, Philippe B, Ghazal F, Jany T, Arnalsteen L, Romon M, Pattou F. Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity. Obes Surg. 2006 Feb;16(2):147-50. doi: 10.1381/096089206775565104. |
| 31399943 | Derived | Vicente Martin C, Rabago Torre LR, Castillo Herrera LA, Arias Rivero M, Perez Ferrer M, Collado Pacheco D, Martin Rios MD, Barba Martin R, Ramiro Martin J, Vazquez-Echarri J, Herrera Merino N. Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay. Surg Endosc. 2020 Jun;34(6):2519-2531. doi: 10.1007/s00464-019-07061-w. Epub 2019 Aug 9. |
| Withdrawal by Subject |
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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-BIBĀ®): 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 |
| BG002 | Total | Total of all reporting groups |
| years OF AGE |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Americam Society of Anestesiologist Physical Status Classification System (ASA) ; ASA score III; | Physical Status Classification System (ASA) ASA classification scores patients ranging from I - V ; ASA I A normal healthy patient Healthy, ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation E , ASA VI A declared brain-dead patient whose organs are being removed for donor purposes .WE MEASURE THE NUMBER of participants IN EACH GROUP classified as ASA III | Number | participants |
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| Starting weight (kg) | the starting weight is expressed in Kg | Mean | Standard Deviation | Kg |
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| Starting body mass index (starting BMI) | Starting body mass index (starting BMI) is expressed in kg/m^2 | Mean | Standard Deviation | "kg/m^2" |
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| Starting body mass index (starting BMI) > 50 ("kg/m^2") | number of patientes with a Starting body mass index (starting BMI) > 50 "kg/m^2" | Count of Participants | Participants |
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| Total weight loss (TWL) | Total weight loss (TWL) is expressed in Kg | Median | Inter-Quartile Range | Kg |
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| Weight before surgery (Kg) | Weight before surgery is expressed in KG | Mean | Standard Deviation | Kg |
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| BMI before surgery("kg/m^2") | Mean | Standard Deviation | "kg/m^2" |
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| Excess weight loss (EWL) before surgery | Excess weight loss (EWL) before surgery is expressed as a percentage % | missing data | Median | Inter-Quartile Range | percentage of EWL |
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| Excess Body Mass Index Loss (EBMIL) before surgery (excess BMI loss) | Median | Inter-Quartile Range | percentage of EBMI loss |
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| Surgery (sleeve resection (LSG)or gastric bypass (LGBP) | Count of Participants | Participants |
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| total body weight loss (TBWL) > 10% | missing data | Count of Participants | Participants |
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| Percentage of Failure of Intragastric Balloon | It was considered that intragastric balloon failed when a total weight loss = or > than 10% of the starting weight has NOT been achieved. The total number of patients with IGB balloon was 41 in this essay, but 9 were excluded post randomization of the final analysis because they were not finally operated. The percentage of IGB balloon failure was calculated for all the patients had intragastric balloon | this variable is not applicable to group B | Count of Participants | Participants |
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| Operation time (hours) | Operation time is expressed in hours | missing data | Mean | Standard Deviation | hours |
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| ICU (hours) intensive care unit | time spent in the intensive care unit is expressed in ICU (hours) | missing data | Median | Inter-Quartile Range | hours) |
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| Primary | 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 ". | Group B did not receive an intra-gastric balloon, and was thus not evaluated for balloon related complications. | Posted | Count of Participants | Participants | during the 6 months having the intragastric balloon and 90 days after surgery |
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| Secondary | Hospital Stay, | all in all hospital stay | Posted | Mean | Standard Deviation | days | the period of the study started when patients were randomizated and finished 90 days after surgery |
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| Secondary | Rate of Surgical Conversion to Open Surgery | number of patients with surgical conversion from laparoscopic to open surgery | Posted | Count of Participants | Participants | during the initial laparoscopic surgery |
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| Secondary | Percentage of Re-operations | Percentage of Re-operations during all the period of the study ending within 90 days after surgery | Posted | Number | percentage of participants | during all the period of the study ending within 90 days after surgery |
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| 0 |
| 34 |
| 2 |
| 34 |
| 8 |
| 34 |
| EG001 | IGB Group A | 32 patients included have a preoperative intragastric balloon during a period of 6 months before operation preoperative intragastric balloon ( IGB-BIBĀ®): 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 | 0 | 32 | 1 | 32 | 7 | 32 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 | Physiological Phenomena |
| Unknown or Not Reported |
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| severe intragastric balloon morbidity |
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| total postsurgical morbidity |
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