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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01950052
First received: September 18, 2013
Last updated: June 8, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention
Obese
Dietary Supplement: Diet group 800 Kcal diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Study the Effects of Preoperative Very Low Calorie Diet on Wound Healing in Morbidly Obese Patients Undergoing Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Collagen 1/3 ratio after diet and surgery [ Time Frame: 7 days following surgery ] [ Designated as safety issue: No ]
    Special immunostains for collagen 1 and 3 will be utilised and their ratio will be calculated by an independent blinded operator


Secondary Outcome Measures:
  • Is there any difference in wound healing between patients undergoing aggressive calorie restriction and those without a dietary intervention prior to bariatric surgery? [ Time Frame: 7 days following surgery ] [ Designated as safety issue: No ]
    Changes in elastin,fibrinogen,myofibroblasts and angiogenesis (formation of new blood vessels) will be evaluated using special immunostains

  • Change in body composition between control group and patients with diet [ Time Frame: At one moth after the diet and 3 months following surgery ] [ Designated as safety issue: No ]
    DEXA scans will be performed for body composition analysis


Other Outcome Measures:
  • Is there any difference in liver volume and fibrosis between control group and patients with diet? [ Time Frame: Outcomes will measured at 1 month compared to baseline values ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
No special diet, patients will continue with a normal diet
Experimental: Diet group
Pre-operative liver shrinking diet of 800 Kcal diet is administered for 4 weeks
Dietary Supplement: Diet group 800 Kcal diet
Pre-operative liver shrinking diet of 800 kcal is administered for 4 weeks
Other Name: VLCD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01950052

Locations
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Ameet G Patel, MS FRCS King's College Hospital NHS Trust
  More Information

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01950052     History of Changes
Other Study ID Numbers: KCH12-109 
Study First Received: September 18, 2013
Last Updated: June 8, 2016
Health Authority: United Kingdom: National Health Service
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by King's College Hospital NHS Trust:
VLCD
Low calorie diet
very low calorie diet
pre-operative diet
liver shrinking diet
bariatric surgery
gastric bypass

ClinicalTrials.gov processed this record on July 28, 2016