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

Not Applicable

• Conditions: Perioperative/Postoperative Complications
• Interventions: Other: Very low-calorie protein-based diet; Other: Hypocaloric diet

• Registration Number: NCT02418975
• Lead Sponsor: San Giuseppe Moscati Hospital

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.

Study Timeline

• Study First Submitted: 2015-03-19
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-17
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very low-calorie protein-based diet	Very low-calorie protein-based diet	Patients will receive a homemade very low-calorie (\~5 kcal/kg of ideal body weight /day) protein-based formula (milk proteins; 1.2 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.
Hypocaloric diet	Hypocaloric diet	Patients will receive a commercial balanced enteral formula (\~20 kcal/kg of ideal body weight /day; protein content, 1.0 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.

Primary Outcome Measures

Name	Time	Method
Surgery duration	End of surgery, an expected average of 3.5 hours	from skin incision to wound closure

Secondary Outcome Measures

Name	Time	Method
Composite intra-operative complications	End of surgery, an expected average of 3.5 hours	Hemorrhage, organ perforation or laceration, conversion to open surgery, stapler dysfunction
Composite post-operative complications	30 days	Any-type hemorrhage, any-type infections, wound dehiscence, anastomotic leak, organ dysfunction
Intra-operative bleeding	End of surgery, an expected average of 3.5 hours
Time to remove surgical drain	Hospital stay, an avarage of 9 days
Total drain fluid production	Hospital stay, an avarage of 9 days
Change of multiple biochemical parameters	End of dietary intervention, 28 days	blood lipids, variables of glucose metabolism and growth-hormone axis
Change of multiple anthropometric parameters	End of dietary intervention, 28 days	body mass index, body weight, waist and hip circumferences
Change in liver fibrosis	End of dietary intervention, 28 days
Change in liver volume	End of dietary intervention, 28 days
Change in visceral fat	End of dietary intervention, 28 days
Change of multiple body composition parameters	End of dietary intervention, 28 days
Change in handgrip strength	End of dietary intervention, 28 days
Change of multiple cardiac morpho-functional parameters	End of dietary intervention, 28 days
Length of hospital stay	Hospital stay, an avarage of 9 days
Composite complications of enteral feeding	End of dietary intervention, 28 days	tube dysfunction, nausea, vomiting, diarrhea
Difficult intubation	Before surgery

Trial Locations

Locations (1)

A.O.R.N. "San Giuseppe Moscati"; 🇮🇹 Avellino, Italy