Study takes air out of pre–bypass intragastric balloon

CHICAGO – Treatment with an intragastric balloon before bariatric surgery produces significant weight loss in the morbidly obese, but at the cost of more surgical complications, according to the prospective randomized BIGPOM trial.

Preoperative weight loss is recommended, and in some cases mandated by third-party payer organizations, to improve comorbidities and postoperative outcomes in the morbidly obese. It’s also been suggested to be a predictive factor of postoperative weight loss, but overall the data are limited and methodological quality of prospective studies in this area poor, Dr. Benoit Coffin said at the annual Digestive Disease Week.

The prospective BIGPOM (Balloon Intra Gastrique Préopératoire Pour Obésité Morbide) study randomly assigned 60 patients to standard medical care and 55 to an air- or water-filled intragastric balloon (IGB) for 6 months before laparoscopic bypass surgery. Their average body mass index was 54.7 kg/m² and 53.9 kg/m², respectively. The average balloon insertion time was 17 minutes and average age in both groups was 40 years.

Weight loss in months 0-6 was significantly higher in the IGB group, compared with standard care (–10.3 kg vs. –3.0 kg; P less than .0001), but did not differ from months 6-12 (–30.4 kg vs. –35.1 kg) or overall from months 0-12 (–40.7 kg vs. –38.1 kg), said Dr. Coffin, of Hôpital Louis Mourier, Colombes, France.

There was no significant difference in weight loss between those treated with water- or air-filled balloons (P = .0.96).

"Preoperative weight loss is not a predictive factor of postoperative weight loss," he said.

Treatment with an IGB, compared with standard care, did not modify operative time (188 minutes vs. 175 minutes), ICU stays greater than 24 hours (71.4% vs. 76%), mean hospital stay (6.8 vs. 6.3 days), or need for laparotomy (2 vs. 1).

Surgical complications, however, were significantly higher with IGB (5 vs. 0; P = .02), and included digestive hemorrhage, intraperitoneal abscess, fistula, peritonitis, occlusion, and reintervention, Dr. Coffin said.

It is not possible to conclude if the increase in complications noted in the group of patients treated by intragastric balloon is the consequence of the balloon itself or the weight loss it induced, he said.

There were no deaths or medical complications in the IGB group, although two patients experienced complications during IGB removal and one patient required surgical removal of the balloon.

Dr. Coffin reported financial relationships with Shire Pharmaceuticals, Cephalon, Almirall, Gerson Lehrman Group, Mayoly-Spindler, and Mundipharma.

pwendling@frontlinemedcom.com

CHICAGO – Treatment with an intragastric balloon before bariatric surgery produces significant weight loss in the morbidly obese, but at the cost of more surgical complications, according to the prospective randomized BIGPOM trial.

Preoperative weight loss is recommended, and in some cases mandated by third-party payer organizations, to improve comorbidities and postoperative outcomes in the morbidly obese. It’s also been suggested to be a predictive factor of postoperative weight loss, but overall the data are limited and methodological quality of prospective studies in this area poor, Dr. Benoit Coffin said at the annual Digestive Disease Week.

The prospective BIGPOM (Balloon Intra Gastrique Préopératoire Pour Obésité Morbide) study randomly assigned 60 patients to standard medical care and 55 to an air- or water-filled intragastric balloon (IGB) for 6 months before laparoscopic bypass surgery. Their average body mass index was 54.7 kg/m² and 53.9 kg/m², respectively. The average balloon insertion time was 17 minutes and average age in both groups was 40 years.

Weight loss in months 0-6 was significantly higher in the IGB group, compared with standard care (–10.3 kg vs. –3.0 kg; P less than .0001), but did not differ from months 6-12 (–30.4 kg vs. –35.1 kg) or overall from months 0-12 (–40.7 kg vs. –38.1 kg), said Dr. Coffin, of Hôpital Louis Mourier, Colombes, France.

There was no significant difference in weight loss between those treated with water- or air-filled balloons (P = .0.96).

"Preoperative weight loss is not a predictive factor of postoperative weight loss," he said.

Treatment with an IGB, compared with standard care, did not modify operative time (188 minutes vs. 175 minutes), ICU stays greater than 24 hours (71.4% vs. 76%), mean hospital stay (6.8 vs. 6.3 days), or need for laparotomy (2 vs. 1).

Surgical complications, however, were significantly higher with IGB (5 vs. 0; P = .02), and included digestive hemorrhage, intraperitoneal abscess, fistula, peritonitis, occlusion, and reintervention, Dr. Coffin said.

It is not possible to conclude if the increase in complications noted in the group of patients treated by intragastric balloon is the consequence of the balloon itself or the weight loss it induced, he said.

There were no deaths or medical complications in the IGB group, although two patients experienced complications during IGB removal and one patient required surgical removal of the balloon.

Dr. Coffin reported financial relationships with Shire Pharmaceuticals, Cephalon, Almirall, Gerson Lehrman Group, Mayoly-Spindler, and Mundipharma.

pwendling@frontlinemedcom.com

CHICAGO – Treatment with an intragastric balloon before bariatric surgery produces significant weight loss in the morbidly obese, but at the cost of more surgical complications, according to the prospective randomized BIGPOM trial.

Preoperative weight loss is recommended, and in some cases mandated by third-party payer organizations, to improve comorbidities and postoperative outcomes in the morbidly obese. It’s also been suggested to be a predictive factor of postoperative weight loss, but overall the data are limited and methodological quality of prospective studies in this area poor, Dr. Benoit Coffin said at the annual Digestive Disease Week.

The prospective BIGPOM (Balloon Intra Gastrique Préopératoire Pour Obésité Morbide) study randomly assigned 60 patients to standard medical care and 55 to an air- or water-filled intragastric balloon (IGB) for 6 months before laparoscopic bypass surgery. Their average body mass index was 54.7 kg/m² and 53.9 kg/m², respectively. The average balloon insertion time was 17 minutes and average age in both groups was 40 years.

Weight loss in months 0-6 was significantly higher in the IGB group, compared with standard care (–10.3 kg vs. –3.0 kg; P less than .0001), but did not differ from months 6-12 (–30.4 kg vs. –35.1 kg) or overall from months 0-12 (–40.7 kg vs. –38.1 kg), said Dr. Coffin, of Hôpital Louis Mourier, Colombes, France.

There was no significant difference in weight loss between those treated with water- or air-filled balloons (P = .0.96).

"Preoperative weight loss is not a predictive factor of postoperative weight loss," he said.

Treatment with an IGB, compared with standard care, did not modify operative time (188 minutes vs. 175 minutes), ICU stays greater than 24 hours (71.4% vs. 76%), mean hospital stay (6.8 vs. 6.3 days), or need for laparotomy (2 vs. 1).

Surgical complications, however, were significantly higher with IGB (5 vs. 0; P = .02), and included digestive hemorrhage, intraperitoneal abscess, fistula, peritonitis, occlusion, and reintervention, Dr. Coffin said.

It is not possible to conclude if the increase in complications noted in the group of patients treated by intragastric balloon is the consequence of the balloon itself or the weight loss it induced, he said.

There were no deaths or medical complications in the IGB group, although two patients experienced complications during IGB removal and one patient required surgical removal of the balloon.

Dr. Coffin reported financial relationships with Shire Pharmaceuticals, Cephalon, Almirall, Gerson Lehrman Group, Mayoly-Spindler, and Mundipharma.

pwendling@frontlinemedcom.com