NATIONAL SURVEY FOR BARIATRIC PROCEDURES IN PEDIATRIC PATIENTS:LONG TIME FOLLOW-UP

1. NATIONAL SURVEY FOR BARIATRIC PROCEDURES IN PEDIATRIC PATIENTS:LONG TIME FOLLOW-UP Castellani RL, Toppino M, Favretto F, Camoglio FS, Zampieri N 1Department of Emergency and Surgery, Clinica Dott.Pederzoli Hospital, Peschiera del Garda, Verona 2Department of Surgery, University of Torino, San Giovanni Battista Hospital –Molinette Hospital, Torino 3Department of Surgery, Clinica Dott.Pederzoli Hospital, Peschiera del Garda, Verona  4Department of Surgery, Pediatric Surgical Unit, University of Verona, AOUI-Policlinico G.B.Rossi, piazzale L.A.Scuro n.1, 37134 Verona , Italy

2. Introduction In 1998 the World Health Organization warned that obesity had reached the rank of a pandemic and that its prevalence was increasing alarmingly, especially in the child population Malta 2017, informal meeting of health Ministers: more than 10% of pediatric population is obese and 25% is overweight and at risk of obesity Non surgical weight loss approach had provided at best 10-15% of excess weight loss in less than 30% of the patients Until effective non surgical treatment becomes available, including pharmacological therapy, bariatric surgery and its procedures are the only viable options for providing durable and significant weight loss as well as improvement of heath conditions for morbidly obese patients No GOLD STANDARD procedure in pediatric age

3. Materials and Methods Study period: 2000-2010 Study population: 13-18 yrs old- S.I.C.O.B. National registry and SICP Inclusion criteria: (BMI) ≥ 40 Kg/m2 or BMI ≥ 35 Kg/m2 with obesity-associated comorbidities according to the international guidelines Exclusion criteria: patients lost to follow-up and patients who had received other bariatric procedures, dependency on alcohol or drugs, subjects with severe learning or cognitive disabilities or emotionally unstable and non responder to %EWL Follow-up: A minimum follow up of 3 years (for 80% of patients) was considered the first criterion for inclusion

4. Results Study population: 173 patients (55 males and 118 females) 65% of patients were from the south of Italy, 30% from the north and 5% from central Italy (p<0.05) Median age at operation was 15.9 ± 1.4 years (range: 13-18 years) (females 16 ± 2 yrs. and males 15 ± 2 yrs.) (p>0.05) Mean BMI before surgery was 44 ± 8 kg/m22 (females 44 ± 9 kg/m22 and males 45 ± 4 kg/m22) (p>0.05) Mean excess weight was 63 ± 24 Kg in females and 71 ± 9 kg in males (p>0.05)

5. Results Comorbidities: hypertension (4 patients), arthropathy (4 patients), obstructive sleep apnea (4 patients), dyspnea (5 patients), dyslipidemia (15 patients), cholelithiasis (4 patients), steatosis (28 patients) and diabetes mellitus (6 patients) Procedures: 85 laparoscopic adjustable gastric band (AGB) 47 patients with endoscopic intragastric balloon (IB) 26 patients with sleeve gastrectomy (SG) 15 patients with malabsorptive techniques (BMI>45, more than 3 comorbidities)^^^ (long magestrasse, minigastric bypass, RYGB)

6. Results Follow-up: 1 year 173/173 (100%) 3 years 142/173 (82%) 5 years 65/173 (35%) 10 years 2/173 (1%) Comorbidities: there was a statically significant improvement in 35% of patients within the first year after procedures, rising to 78% of patients within 5 years. (p<0.05) Hospial stay and surgical complications: no differences between study population and literature Only few patients had data about band and IB removal

7. Results BMI: significant decrease in mean BMI for each procedure at 5 years AGB group: 33 ± 3 kg/m2 (pre-op 44 ± 6 kg/m2) SG group: 32 ± 4 kg/m2 (pre-op 46 ± 8 kg/m2) IB group: 33 ± 6 kg/m2 (pre-op 43 ± 6 kg/m2) MT group: 30 ± 2kg/ m2 (pre-op 46 ± 8 kg/m2) %EWL (3 years) AGB group: 43±10% SG group: 56±14% IB group: 68±18% MT group: 77±20% There were no cases of non-responders (%EWL< 30%) at 3 years.

8. Discussion A randomized trial by O'Brien et al comparing lifestyle intervention and bariatric surgery (laparoscopic gastric banding), demonstrated favorable weight loss and improvements in cardiovascular factors, as well as improved quality of life in the surgically treated group There is emerging literature about bariatric surgery in adolescents, but data remains limited. Based on current evidence, as reported for adults, bariatric surgery offers weight loss and improvements also in adolescent patients’ health A recent meta-analysis reported a complication rate comparable to that of adults, indicating that these procedures are safe also for pediatric patients (complication rates of 22%−33% for RYGB, 4.3% for SG, and 10%−48% for AGB)

9. Discussion J Clin Endocrinol Metab. 2017 Treatment of Pediatric Obesity: An Umbrella Systematic Review. Physical activity interventions (low to moderate quality of evidence) Dietary interventions with low-carbohydrate diets (moderate quality of evidence) Educational interventions reduced waist circumference, BMI, and diastolic blood pressure (low quality of evidence). Surgical interventions (laparoscopic adjustable gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy) resulted in the largest BMI reduction But... Less is still known about the management of IB in pediatric age Less is still known about the management of AGB

10. Conclusions Considering the different techniques available in this field, in adolescent patients we advocate the use of those techniques preserving an intact gastrointestinal tract The use of sleeve gastrectomy is safe and useful to achieve high and stable %EWL Other less invasive techniques, such as AGB or intragastric balloon insertion, offer satisfactory results and could be used as an alternative to SG At 6 months there was not a statistical differences in BMI and % EWL between study groups but this change after 1 year (important for patients and parents) Comparing these data with the Literature about pediatric obesity, at 3 years surgical %EWL is better than non surgical management This data is also confirmed for comorbidities

11. Conclusions THIS IS THE FIRST REPORT ABOUT A NATIONAL REGISTRY IN LITERATURE OPEN QUESTIONS: Does This National registry need a structured section for adolescents? Have these patients a good post-op follow-up? Have these patients a multidisciplinary pediatric team? Have these patients GP informed about follow-up?