Pre-operative Diet: Effect of Wound Healing After Bariatric Surgery

NCT01950052 | Unknown

• 1 other identifier: KCH12-109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomised control trial comparing the effects of a pre-operative very low calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric surgery. The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of shrinking the liver to make surgery easier. Studies have shown that after this diet the liver does shrink and therefore operating may be easier but this did not necessary translate into significant lesser operative times. The effects of operating during a catabolic phase have not been evaluated. Theoretically a low calorie diet before surgery is similar to starving a patient and can potentially create a state of malnutrition. This is rarely advisable before surgery and can lead to poor wound healing and poor healing of bowel anastomosis. This study will ascertain if there is any difference in wound healing rates in these morbidly obese patients (BMI\>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in groups who have taken the preoperative diet compared to those who were not on a special diet. Skin wounds will be evaluated. This will potentially reflect the general state of healing of the patient which includes the healing of bowel anastomosis. Surrogate markers will be employed to evaluate the pre-morbid nutritional state, effectiveness of dieting, subsequent wound healing (collagen production, markers for the different aspects of wound healing) and impact on liver cell death .This study will be able to tell us how safe this calorie deficient diet is in these morbidly obese patients before surgery.

Conditions

Obese

Keywords

VLCD; Low calorie diet; very low calorie diet; pre-operative diet; liver shrinking diet; bariatric surgery; gastric bypass

Outcome Measures

Primary Outcomes (1)

• Collagen 1/3 ratio after diet and surgery

  Special immunostains for collagen 1 and 3 will be utilised and their ratio will be calculated by an independent blinded operator

  7 days following surgery

Secondary Outcomes (2)

• Is there any difference in wound healing between patients undergoing aggressive calorie restriction and those without a dietary intervention prior to bariatric surgery?

  7 days following surgery

• Change in body composition between control group and patients with diet

  At one moth after the diet and 3 months following surgery

Other Outcomes (1)

• Is there any difference in liver volume and fibrosis between control group and patients with diet?

  Outcomes will measured at 1 month compared to baseline values

Study Arms (2)

Control group

NO INTERVENTION

No special diet, patients will continue with a normal diet

Diet group

EXPERIMENTAL

Pre-operative liver shrinking diet of 800 Kcal diet is administered for 4 weeks

Dietary Supplement: Diet group 800 Kcal diet

Interventions

Diet group 800 Kcal diet DIETARY_SUPPLEMENT

Pre-operative liver shrinking diet of 800 kcal is administered for 4 weeks

Also known as: VLCD

Diet group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have given written informed consent
• Patients who are able to understand and comply with protocol requirements
• Patients 18-70 years old
• Patients scheduled for Laparoscopic Roux En Y Gastric Bypass
• Patients with BMI \> 40 and \< 60

You may not qualify if:

• Unable or unwilling to give an informed written consent
• Cognitive impairment or mental retardation
• Patient who do not understand or follow protocol requirements
• Severe hepatic impairment or portal hypertension
• Pregnancy and lactation
• Diabetes
• Pre-existing chronic inflammatory disease
• Overt psychosis
• Porphyria
• Advanced renal disease
• Acute cerebrovascular or cardiovascular disease
• Patients with alcohol or drug addiction
• Patients taking medication known to impact wound healing (eg glucocorticosteroids, chemotherapy, immunosuppressant)
• Patients who lose less than 5% of body weight after 4 weeks of the diet

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ameet G Patel, MS FRCS

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 25, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 9, 2016

Record last verified: 2016-02

Locations

GB (1)