B Coffin1,2, V Maunoury3,4, F Pattou3,4, X Hébuterne5,6, S Schneider5,6, M Coupaye7,8, S Ledoux7,8, F Iglicki7,8, F Mion9,10, M Robert9,10, E Disse9,10, J Escourrou11,12, G Tuyeras11,12, Y Le Roux13, C Arvieux14,15, P Pouderoux16,17, N Huten18,19, T Alfaiate20, D Hajage20, S Msika7,8. 1. AP-HP Hopital Louis Mourier, Colombes, France. benoit.coffin@aphp.fr. 2. Université Denis Diderot-Paris 7, Paris, France. benoit.coffin@aphp.fr. 3. CHU Lille, Lille, France. 4. Université Lille-2, Lille, France. 5. Hopital de l'Archet, Nice, France. 6. Université de Nice, Nice, France. 7. AP-HP Hopital Louis Mourier, Colombes, France. 8. Université Denis Diderot-Paris 7, Paris, France. 9. Hospices Civils de Lyon, Lyon, France. 10. Université Lyon 1, Lyon, France. 11. CHU de Toulouse Rangueil, Toulouse, France. 12. Université Toulouse, Toulouse, France. 13. CHU Caen, Caen, France. 14. CHU de Grenoble and Faculté de Médecine de Grenoble, Grenoble, France. 15. Université Joseph Fournier, Grenoble, France. 16. CHU de Nîmes, Nîmes, France. 17. Université de Nîmes, Nîmes, France. 18. CHU de Tours, France, France. 19. Université de Tours, France, France. 20. AP-HP Hôpital Bichat, Paris, France.
Abstract
BACKGROUND:Super obese patients are recommended to lose weight before bariatric surgery. The effect of intragastric balloon (IGB)-induced weight loss before laparoscopic gastric bypass (LGBP) has not been reported. The aim of this prospective randomized multicenter study was to compare the impact of preoperative 6-month IGB with standard medical care (SMC) in LGBP patients. METHODS:Patients with BMI >45 kg/m2 selected for LGBP were included and randomized to receive either SMC or IGB. After 6 months (M6), the IGB was removed and LGBP was performed in both groups. Postoperative follow-up period was 6 months (M12). The primary endpoint was the proportion of patients requiring ICU stay >24 h; secondary criteria were weight changes, operative time, hospitalization stay, and perioperative complications. RESULTS:Only 115 patients were included (BMI 54.3 ± 8.7 kg/m2), of which 55 underwent IGB insertion. The proportion of patients who stayed in ICU >24 h was similar in both groups (P = 0.87). At M6, weight loss was significantly greater in the IGB group than in the SMC group (P < 0.0001). Three severe complications occurred during IGB removal. Mean operative time for LGBP was similar in both groups (P = 0.49). Five patients had 1 or more surgical complications, all in the IGB group (P = 0.02). Both groups had similar hospitalization stay (P = 0.59) and weight loss at M12 (P = 0.31). CONCLUSION: IGB insertion before LGBP induced weight loss but did not improve the perioperative outcomes or affect postoperative weight loss.
RCT Entities:
BACKGROUND: Super obesepatients are recommended to lose weight before bariatric surgery. The effect of intragastric balloon (IGB)-induced weight loss before laparoscopic gastric bypass (LGBP) has not been reported. The aim of this prospective randomized multicenter study was to compare the impact of preoperative 6-month IGB with standard medical care (SMC) in LGBP patients. METHODS:Patients with BMI >45 kg/m2 selected for LGBP were included and randomized to receive either SMC or IGB. After 6 months (M6), the IGB was removed and LGBP was performed in both groups. Postoperative follow-up period was 6 months (M12). The primary endpoint was the proportion of patients requiring ICU stay >24 h; secondary criteria were weight changes, operative time, hospitalization stay, and perioperative complications. RESULTS: Only 115 patients were included (BMI 54.3 ± 8.7 kg/m2), of which 55 underwent IGB insertion. The proportion of patients who stayed in ICU >24 h was similar in both groups (P = 0.87). At M6, weight loss was significantly greater in the IGB group than in the SMC group (P < 0.0001). Three severe complications occurred during IGB removal. Mean operative time for LGBP was similar in both groups (P = 0.49). Five patients had 1 or more surgical complications, all in the IGB group (P = 0.02). Both groups had similar hospitalization stay (P = 0.59) and weight loss at M12 (P = 0.31). CONCLUSION: IGB insertion before LGBP induced weight loss but did not improve the perioperative outcomes or affect postoperative weight loss.
Authors: A Genco; M Cipriano; V Bacci; M Cuzzolaro; A Materia; L Raparelli; C Docimo; M Lorenzo; N Basso Journal: Int J Obes (Lond) Date: 2006-01 Impact factor: 5.095
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