Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition

San Giuseppe Moscati Hospital140 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Surgery duration

from skin incision to wound closure

Time frame: End of surgery, an expected average of 3.5 hours

Secondary Outcomes

Composite intra-operative complications

Hemorrhage, organ perforation or laceration, conversion to open surgery, stapler dysfunction

Time frame: End of surgery, an expected average of 3.5 hours

Composite post-operative complications

Any-type hemorrhage, any-type infections, wound dehiscence, anastomotic leak, organ dysfunction

Time frame: 30 days

Intra-operative bleeding

Time frame: End of surgery, an expected average of 3.5 hours

Difficult intubation

Time frame: Before surgery

Time to remove surgical drain

Time frame: Hospital stay, an avarage of 9 days

Total drain fluid production

Time frame: Hospital stay, an avarage of 9 days

Change of multiple biochemical parameters

blood lipids, variables of glucose metabolism and growth-hormone axis