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

Morbid Obesity Clinical Trial

Official title:

Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998243
• Other study ID #: fis PI070682
• Secondary ID: FIS PI070682
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: November 2016

Study information

• Verified date: March 2019
• Source: Hospital Severo Ochoa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Device:
• Intragastric Balloon (IGB), group A
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

Other:
• diet, control group B
the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet

Locations

Country	Name	City	State
Spain	Gastroenterology Department ,Severo Ochoa Hospital	Leganés	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Severo Ochoa	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	within the 90 days after surgery
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 ".	during the 6 months having the intragastric balloon and 90 days after surgery
Secondary	Hospital Stay,	all in all hospital stay	the period of the study started when patients were randomizated and finished 90 days after surgery
Secondary	Rate of Surgical Conversion to Open Surgery	number of patients with surgical conversion from laparoscopic to open surgery	during the initial laparoscopic surgery
Secondary	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