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

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

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.

Study Overview

• Status: Unknown
• Conditions: Perioperative/Postoperative Complications
• Intervention / Treatment: Other: Very low-calorie protein-based diet; Other: Hypocaloric diet

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Avellino, Italy
    • Recruiting
    • A.O.R.N. "San Giuseppe Moscati"
    • Contact: Giuseppe Castaldo, MD; Phone Number: 00390825203358; Email: lavoronep@yahoo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery duration	from skin incision to wound closure	End of surgery, an expected average of 3.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite intra-operative complications	Hemorrhage, organ perforation or laceration, conversion to open surgery, stapler dysfunction	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	30 days
Intra-operative bleeding		End of surgery, an expected average of 3.5 hours
Difficult intubation		Before surgery
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	blood lipids, variables of glucose metabolism and growth-hormone axis	End of dietary intervention, 28 days
Change of multiple anthropometric parameters	body mass index, body weight, waist and hip circumferences	End of dietary intervention, 28 days
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	tube dysfunction, nausea, vomiting, diarrhea	End of dietary intervention, 28 days

Collaborators and Investigators

• Sponsor: San Giuseppe Moscati Hospital
• Investigators: Principal Investigator: Giuseppe Castaldo, MD, A.O.R.N. "San Giuseppe Moscati"

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: CECN/132