Clinical trial NCT01998243: Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity
Official title: Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: morbid obesity
bioenterics intragastric balloon
bariatric surgery
Lead sponsor: Hospital Severo Ochoa
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-11-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Postsurgical Morbidity on Both Arms of the Study
timeFrame: within the 90 days after surgery
measure: Total Postsurgical Morbidity
timeFrame: during the 6 months having the intragastric balloon and 90 days after surgery
Secondary outcomes:
measure: Hospital Stay,
timeFrame: the period of the study started when patients were randomizated and finished 90 days after surgery
measure: Rate of Surgical Conversion to Open Surgery
timeFrame: during the initial laparoscopic surgery
measure: Percentage of Re-operations
timeFrame: during all the period of the study ending within 90 days after surgery
Other outcomes:
Locations:
city: Leganés
country: Spain
facility: Gastroenterology Department ,Severo Ochoa Hospital
state: Madrid
Study officials:
name: Luis R Rábago, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.