Perioperative/Postoperative ComplicationsNCT02418975
Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition
A study testing Very low-calorie protein-based diet and Hypocaloric diet in people with Perioperative/Postoperative Complications, run by San Giuseppe Moscati Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Very low-calorie protein-based diet and Hypocaloric diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O.R.N. "San Giuseppe Moscati"
Avellino
Giuseppe Castaldo, MD, 00390825203358, lavoronep@yahoo.it
About this study
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
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.
Read the 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.
- Being tested
- Very low-calorie protein-based diet, Hypocaloric diet
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low-calorie protein-based dietOther
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hypocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery duration
from skin incision to wound closure
Measured: End of surgery, an expected average of 3.5 hours
Secondary outcomes (16)
Composite intra-operative complications
Hemorrhage, organ perforation or laceration, conversion to open surgery, stapler dysfunction
Measured: 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
Measured: 30 days
Intra-operative bleeding
Measured: End of surgery, an expected average of 3.5 hours
Difficult intubation
Measured: Before surgery
Time to remove surgical drain
Measured: Hospital stay, an avarage of 9 days
Total drain fluid production
Measured: Hospital stay, an avarage of 9 days
Change of multiple biochemical parameters
blood lipids, variables of glucose metabolism and growth-hormone axis
Measured: End of dietary intervention, 28 days
Change of multiple anthropometric parameters
body mass index, body weight, waist and hip circumferences
Measured: End of dietary intervention, 28 days
Change in liver fibrosis
Measured: End of dietary intervention, 28 days
Change in liver volume
Measured: End of dietary intervention, 28 days
Change in visceral fat
Measured: End of dietary intervention, 28 days
Change of multiple body composition parameters
Measured: End of dietary intervention, 28 days
Change in handgrip strength
Measured: End of dietary intervention, 28 days
Change of multiple cardiac morpho-functional parameters
Measured: End of dietary intervention, 28 days
Length of hospital stay
Measured: Hospital stay, an avarage of 9 days
Composite complications of enteral feeding
tube dysfunction, nausea, vomiting, diarrhea
Measured: End of dietary intervention, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Giuseppe Moscati Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Castaldo, San Giuseppe Moscati Hospital
- Investigators
- Giuseppe Castaldo, MD, Principal investigator, A.O.R.N. "San Giuseppe Moscati"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418975
- Sponsor's protocol ID
- CECN/132
- Status last verified
- Mar 2017
- First submitted
- 19 Mar 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24366220Sukkar 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.
PubMed 24027606
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02418975
- Acronym / sponsor ID
- CECN/132
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- San Giuseppe Moscati HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low-calorie protein-based diet | Experimental | Other: Very low-calorie protein-based dietPatients 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 | Active comparator | Other: Hypocaloric dietPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low-calorie protein-based dietPatients 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 dietPatients 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 |
Primary outcome
Surgery duration
Time frame: End of surgery, an expected average of 3.5 hours
from skin incision to wound closure
16 secondary outcomes
Composite intra-operative complications
Time frame: End of surgery, an expected average of 3.5 hours
Composite post-operative complications
Time frame: 30 days
Intra-operative bleeding
Time frame: End of surgery, an expected average of 3.5 hours
Difficult intubation
Time frame: Before surgery
Time to remove surgical drain
Time frame: Hospital stay, an avarage of 9 days
Total drain fluid production
Time frame: Hospital stay, an avarage of 9 days
Change of multiple biochemical parameters
Time frame: End of dietary intervention, 28 days
Change of multiple anthropometric parameters
Time frame: End of dietary intervention, 28 days
Change in liver fibrosis
Time frame: End of dietary intervention, 28 days
Change in liver volume
Time frame: End of dietary intervention, 28 days
Change in visceral fat
Time frame: End of dietary intervention, 28 days
Change of multiple body composition parameters
Time frame: End of dietary intervention, 28 days
Change in handgrip strength
Time frame: End of dietary intervention, 28 days
Change of multiple cardiac morpho-functional parameters
Time frame: End of dietary intervention, 28 days
Length of hospital stay
Time frame: Hospital stay, an avarage of 9 days
Composite complications of enteral feeding
Time frame: End of dietary intervention, 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Background: PubMed 24366220Monaco 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.
- Background: PubMed 24027606Sukkar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Castaldo, MD principal investigator
A.O.R.N. "San Giuseppe Moscati"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low-calorie protein-based diet and Hypocaloric diet in people with Perioperative/Postoperative Complications, run by San Giuseppe Moscati Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Castaldo, MD (00390825203358, lavoronep@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery duration (time frame: End of surgery, an expected average of 3.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418975, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.