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

NCT02418975 | Unknown

• 1 other identifier: CECN/132
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Surgery duration

  from skin incision to wound closure

  End of surgery, an expected average of 3.5 hours

Secondary Outcomes (16)

• Composite intra-operative complications

  End of surgery, an expected average of 3.5 hours

• Composite post-operative complications

  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

Study Arms (2)

Very low-calorie protein-based diet

EXPERIMENTAL

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

Hypocaloric diet

ACTIVE COMPARATOR

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

Interventions

Very low-calorie protein-based diet OTHER

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.

Very low-calorie protein-based diet

Hypocaloric diet OTHER

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.

Hypocaloric diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• month previous cardio-vascular disease
• pregnancy and/or lactation
• current/previous neoplastic disease
• psychiatric disorders
• know gastro-intestinal diseases
• other controindications to enteral nutrition

Sponsors & Collaborators

• San Giuseppe Moscati Hospital: lead

Study Sites (1)

A.O.R.N. "San Giuseppe Moscati"

Avellino, Italy

RECRUITING

Related 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.

  PMID: 24366220 BACKGROUND

• 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.

  PMID: 24027606 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Castaldo, MD

  A.O.R.N. "San Giuseppe Moscati"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Castaldo, MD

CONTACT

00390825203358; lavoronep@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

IT (1)