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

Perioperative/Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02418975
• Other study ID #: CECN/132
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2015
• Last updated: March 17, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: San Giuseppe Moscati Hospital
• Contact: Giuseppe Castaldo, MD
• Phone: 00390825203358
• Email: lavoronep[@]yahoo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	A.O.R.N. "San Giuseppe Moscati"	Avellino

Sponsors (1)

Lead Sponsor	Collaborator
San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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;6:165-176. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery duration	from skin incision to wound closure	End of surgery, an expected average of 3.5 hours
Secondary	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
Secondary	Composite post-operative complications	Any-type hemorrhage, any-type infections, wound dehiscence, anastomotic leak, organ dysfunction	30 days
Secondary	Intra-operative bleeding		End of surgery, an expected average of 3.5 hours
Secondary	Difficult intubation		Before surgery
Secondary	Time to remove surgical drain		Hospital stay, an avarage of 9 days
Secondary	Total drain fluid production		Hospital stay, an avarage of 9 days
Secondary	Change of multiple biochemical parameters	blood lipids, variables of glucose metabolism and growth-hormone axis	End of dietary intervention, 28 days
Secondary	Change of multiple anthropometric parameters	body mass index, body weight, waist and hip circumferences	End of dietary intervention, 28 days
Secondary	Change in liver fibrosis		End of dietary intervention, 28 days
Secondary	Change in liver volume		End of dietary intervention, 28 days
Secondary	Change in visceral fat		End of dietary intervention, 28 days
Secondary	Change of multiple body composition parameters		End of dietary intervention, 28 days
Secondary	Change in handgrip strength		End of dietary intervention, 28 days
Secondary	Change of multiple cardiac morpho-functional parameters		End of dietary intervention, 28 days
Secondary	Length of hospital stay		Hospital stay, an avarage of 9 days
Secondary	Composite complications of enteral feeding	tube dysfunction, nausea, vomiting, diarrhea	End of dietary intervention, 28 days