Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay

Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay

Introduction There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery. Method Prospective randomised study of patients with morbid obesity treated...

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Published in:Surgical endoscopy Vol. 34; no. 6; pp. 2519 - 2531
Main Authors: Vicente Martin, Cristina, Rabago Torre, Luis R., Castillo Herrera, Luis A., Arias Rivero, Marisa, Perez Ferrer, Miguel, Collado Pacheco, David, Martin Rios, Maria Dolores, Barba Martin, Raquel, Ramiro Martin, Javier, Vazquez-Echarri, Jaime, Herrera Merino, Norberto
Format: Journal Article
Language:English
Published: New York Springer US 01-06-2020
Springer Nature B.V
Subjects:
Abdominal Surgery
Gastroenterology
Gastrointestinal surgery
Gynecology
Hepatology
Medicine
Medicine & Public Health
Morbidity
NCT
NCT01998243
Obesity
Postoperative period
Proctology
Surgery
Weight control
Surgical morbidity
Vertical gastrectomy
Morbid obesity
Laparoscopic bariatric surgery
Gastric bypass
Intragastric balloon
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Summary:Introduction There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery. Method Prospective randomised study of patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm), where an IGB was inserted within the 6 months before surgery, and the control arm (C-arm). Results The study included 66 patients: 65.6% women, 69.6% with bypass. Age: 43 years (SD 10.2) B-arm and 42.6 years (SD 9.2) in the C-arm. We found 34.4% therapeutic failures in IGB. The mean body weight loss, %EWL and BMI reduction before surgery was 16.2 kg (SD 9.84) B-arm versus 4.7 (SD 8.70) in the C-arm, 23.6% versus 4.7% ( p  < 0.001) and 6.04 versus 1 ( p  < 0.001), respectively. The hospital stay was 7 days (p 25–75 : 5–8) B-arm and 7 days (p 25–75 : 5–9) in the C-arm ( p = 0.937). Post-surgical morbidity with IGB was 25% versus 29.5% in the C-arm, p = 0.689. The number needed to treat (NNT) to prevent of post-surgical morbidity was 23 patients. The B-arm presented 54.5% moderate-severe post-surgical adverse events (12.5%) versus 82.6% in the C-arm (23.5%), p = 0.111. The cost of placing a balloon was more than 4000 Euros each. Conclusions The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations. The balloon achieves a higher weight loss result when compared to a diet programme, its added cost must also be given due consideration. Trail Registry This study has been registered on ClinicalTrials.gov with the Identifier: NCT01998243 (November 28, 2013).
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ISSN:0930-2794
1432-2218
DOI:10.1007/s00464-019-07061-w