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

Primary Purpose

Perioperative/Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Very low-calorie protein-based diet
Hypocaloric diet
Sponsored by
San Giuseppe Moscati Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative/Postoperative Complications

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Very low-calorie protein-based diet

Hypocaloric diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Surgery duration
from skin incision to wound closure

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2015
Last Updated
March 17, 2017
Sponsor
San Giuseppe Moscati Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02418975
Brief Title
Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Giuseppe Moscati Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very low-calorie protein-based diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypocaloric diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Very low-calorie protein-based diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hypocaloric diet
Intervention Description
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 Measure Information:
Title
Surgery duration
Description
from skin incision to wound closure
Time Frame
End of surgery, an expected average of 3.5 hours
Secondary Outcome Measure Information:
Title
Composite intra-operative complications
Description
Hemorrhage, organ perforation or laceration, conversion to open surgery, stapler dysfunction
Time Frame
End of surgery, an expected average of 3.5 hours
Title
Composite post-operative complications
Description
Any-type hemorrhage, any-type infections, wound dehiscence, anastomotic leak, organ dysfunction
Time Frame
30 days
Title
Intra-operative bleeding
Time Frame
End of surgery, an expected average of 3.5 hours
Title
Difficult intubation
Time Frame
Before surgery
Title
Time to remove surgical drain
Time Frame
Hospital stay, an avarage of 9 days
Title
Total drain fluid production
Time Frame
Hospital stay, an avarage of 9 days
Title
Change of multiple biochemical parameters
Description
blood lipids, variables of glucose metabolism and growth-hormone axis
Time Frame
End of dietary intervention, 28 days
Title
Change of multiple anthropometric parameters
Description
body mass index, body weight, waist and hip circumferences
Time Frame
End of dietary intervention, 28 days
Title
Change in liver fibrosis
Time Frame
End of dietary intervention, 28 days
Title
Change in liver volume
Time Frame
End of dietary intervention, 28 days
Title
Change in visceral fat
Time Frame
End of dietary intervention, 28 days
Title
Change of multiple body composition parameters
Time Frame
End of dietary intervention, 28 days
Title
Change in handgrip strength
Time Frame
End of dietary intervention, 28 days
Title
Change of multiple cardiac morpho-functional parameters
Time Frame
End of dietary intervention, 28 days
Title
Length of hospital stay
Time Frame
Hospital stay, an avarage of 9 days
Title
Composite complications of enteral feeding
Description
tube dysfunction, nausea, vomiting, diarrhea
Time Frame
End of dietary intervention, 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Castaldo, MD
Phone
00390825203358
Email
lavoronep@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Castaldo, MD
Organizational Affiliation
A.O.R.N. "San Giuseppe Moscati"
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.R.N. "San Giuseppe Moscati"
City
Avellino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Castaldo, MD
Phone
00390825203358
Email
lavoronep@yahoo.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
24366220
Citation
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.
Results Reference
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PubMed Identifier
24027606
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(2):165-176. doi: 10.1007/s12349-013-0126-2. Epub 2013 May 30.
Results Reference
background

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

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