Clinical trial NCT02418975: Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition
Official title: Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition to Improve Intra- and Post-operative Outcomes of Severely Obese Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative/Postoperative Complications
Lead sponsor: San Giuseppe Moscati Hospital
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Detailed description: Bariatric surgery is an important treatment strategy for obese patients having failed multiple diet-induced weight loss attempts. On the other hand, severly obese patients have also a high risk of both intra- and post-operative complications. Pre-operative weight loss can reduce these risks but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Eligibility criteria: Inclusion Criteria:

* patient candidate to laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy) after multi-disciplinary pre-operative evaluation
* Availability to long-term post-operative follow-up
* Normal kidney function serum creatinine ≤ 1,2 mg/dL and glomerular filtration rate ≥ 90 mL/min
* Normal liver function (aspartate amino-transferase and/or alanine amino-transferase and/or gamma glutamyl transferase \< 2 x N)
* written informed consent

Exclusion Criteria:

* age \<18 or \>60 anni
* serum creatinine \>1,2 mg/dl
* liver failure (Child-Pugh ≥ A)
* insuline-dependent diabetes mellitus
* atrioventricular block with QT \> 0,44 ms
* Cardiac arrythmias
* Moderate-severe cardiac failure
* Hypokaliemia
* Chronic diarrhoea or vomitus
* 12-month previous cardio-vascular disease
* pregnancy and/or lactation
* current/previous neoplastic disease
* psychiatric disorders
* know gastro-intestinal diseases
* other controindications to enteral nutrition
* moderate-severe hypo-albuminemia (\<3.0 mg/dL)
* 6-month previous diet-induced weight loss
* intragastric balloon
* unavailability to planned measurements

Primary outcomes:
measure: Surgery duration
timeFrame: End of surgery, an expected average of 3.5 hours
Secondary outcomes:
measure: Composite intra-operative complications
timeFrame: End of surgery, an expected average of 3.5 hours
measure: Composite post-operative complications
timeFrame: 30 days
measure: Intra-operative bleeding
timeFrame: End of surgery, an expected average of 3.5 hours
measure: Difficult intubation
timeFrame: Before surgery
measure: Time to remove surgical drain
timeFrame: Hospital stay, an avarage of 9 days
measure: Total drain fluid production
timeFrame: Hospital stay, an avarage of 9 days
measure: Change of multiple biochemical parameters
timeFrame: End of dietary intervention, 28 days
measure: Change of multiple anthropometric parameters
timeFrame: End of dietary intervention, 28 days
measure: Change in liver fibrosis
timeFrame: End of dietary intervention, 28 days
measure: Change in liver volume
timeFrame: End of dietary intervention, 28 days
measure: Change in visceral fat
timeFrame: End of dietary intervention, 28 days
measure: Change of multiple body composition parameters
timeFrame: End of dietary intervention, 28 days
measure: Change in handgrip strength
timeFrame: End of dietary intervention, 28 days
measure: Change of multiple cardiac morpho-functional parameters
timeFrame: End of dietary intervention, 28 days
measure: Length of hospital stay
timeFrame: Hospital stay, an avarage of 9 days
measure: Composite complications of enteral feeding
timeFrame: End of dietary intervention, 28 days
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: A.O.R.N. "San Giuseppe Moscati"
Study officials:
affiliation: A.O.R.N. "San Giuseppe Moscati"
name: Giuseppe Castaldo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monaco L, Monaco M, Di Tommaso L, Stassano P, Castaldo L, Castaldo G. Aortomesenteric fat thickness with ultrasound predicts metabolic diseases in obese patients. Am J Med Sci. 2014 Jan;347(1):8-13. doi: 10.1097/MAJ.0b013e318288f795.
citation: Sukkar SG, Signori A, Borrini C, Barisione G, Ivaldi C, Romeo C, Gradaschi R, Machello N, Nanetti E, Vaccaro AL. Feasibility of protein-sparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test). Med J Nutrition Metab. 2013;6(2):165-176. doi: 10.1007/s12349-013-0126-2. Epub 2013 May 30.