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

NCT01998243 | Completed Results DMC

• 2 other identifiers: fis PI070682FIS PI070682
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

morbid obesity; bioenterics intragastric balloon; bariatric surgery

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

  during the initial laparoscopic surgery

• Percentage of Re-operations

  during all the period of the study ending within 90 days after surgery

Study Arms (2)

IGB group A

EXPERIMENTAL

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

control group B

PLACEBO COMPARATOR

the intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal)

Other: diet, control group B

Interventions

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

Also known as: BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM

IGB group A

diet, control group B OTHER

the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet

Also known as: 1200 Kilocalories (Kcal) diet

IGB group A; control group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospital Severo Ochoa: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Gastroenterology Department ,Severo Ochoa Hospital

Leganés, Madrid, 28911, Spain

Location

Related Publications (7)

• 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.

  PMID: 11433910 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.

  PMID: 11433911 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.

  PMID: 12194556 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.

  PMID: 15186637 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.

  PMID: 15329191 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.

  PMID: 16469215 BACKGROUND

• 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.

  PMID: 31399943 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Drug Delivery Systems; Diet

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

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

Results Point of Contact

• Title: Dr Luis Ramon Rabago Torre
• Organization: Hospital severo ochoa

lrabagot@gmail.com

34914818000

Study Officials

• Luis R Rábago, MD,PhD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Phd Luis Ramon Rábago Torre

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 28, 2013
• Study Start: January 1, 2009
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)