Randomised Controlled Trial to Study the Effects of Preoperative Very Low Calorie Diet on Wound Healing in Morbidly Obese Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Collagen 1/3 ratio after diet and surgery
研究概览
简要总结
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.
详细描述
Study Design:
Prospective single blinded randomised controlled study
Null hypothesis: There is no difference in wound healing between patients on a very low calorie diet and those not on a diet prior to a Laparoscopic Roux en Y gastric bypass (LRYGB)
Participants:
All patients referred to King's College Hospital for weight loss surgery who are morbidly obese (BMI>40) who undergo LRYGB will be eligible. All patients undergo an introductory group education session after which they are counselled one to one where the patient and the clinician decide on the most appropriate bariatric procedure. Only those who will undergo a laparoscopic roux en y gastric bypass will be offered the opportunity to participate in the study by a member of the research team. The study is open to all irrespective of age, sex, ethnicity and religion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Collagen 1/3 ratio after diet and surgery
时间窗: 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
次要结局
- 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)