Pre-operative Diet: Effect of Wound Healing After Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT01950052|
Recruitment Status : Unknown
Verified February 2016 by King's College Hospital NHS Trust.
Recruitment status was: Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : June 9, 2016
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 or disease||Intervention/treatment||Phase|
|Obese||Dietary Supplement: Diet group 800 Kcal diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||January 2017|
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
- Collagen 1/3 ratio after diet and surgery [ Time Frame: 7 days following surgery ]Special immunostains for collagen 1 and 3 will be utilised and their ratio will be calculated by an independent blinded operator
- 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 ]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 ]DEXA scans will be performed for body composition analysis
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950052
|King's College Hospital NHS Foundation Trust|
|London, United Kingdom, SE5 9RS|
|Principal Investigator:||Ameet G Patel, MS FRCS||King's College Hospital NHS Trust|