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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery duration | from skin incision to wound closure | End of surgery, an expected average of 3.5 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Castaldo, MD | Contact | 00390825203358 | lavoronep@yahoo.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Castaldo, MD | A.O.R.N. "San Giuseppe Moscati" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.R.N. "San Giuseppe Moscati" | Recruiting | Avellino | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24366220 | Background | 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. | |
| 24027606 | 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. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
|
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 |