The Effect of Single Anastomosis Sleeve Jejunal Bypass versus Sleeve Gastrectomy on Nutritional Deficiency following Bariatric Surgery: An exploratory Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the nutritional deficiency between two bariatric bypass surgery
研究概览
简要总结
1. According to ICMR-INDIAB study 2015. 5% of Indian population is obese; that is about 8 crore population is suffering from obesity.
2. Bariatric procedures have started to gain popularity in India. A total of 20,242 procedures were performed in 2018 which was a rise of approximately 86% from 2014.
3. There is an on-going debate between different bariatric procedures (SG, MGB and Roux-en-Y and sleeve plus) on their efficacy (adequate weight loss, remission of comorbidities and least nutritional deficiency). Existing literature suggests that all bariatric surgical procedures are compliance dependent (diet, exercise etc.), and the most commonly performed bariatric surgery in India and the world is Sleeve Gastrectomy. However, the weight regain and return of comorbidities was more with SG than with the bypass procedures.
4. The bypass (Roux-en-Y and MGB) procedures showed consistent weight loss and remission of co-morbidities following bypass procedures on long term (7 to 10 year) follow up. However, patients have higher rates of nutritional deficiencies (macro and micronutrient) when compared to SG. Therefore, a few surgeons came out with sleeve plus (SASI, SADI, etc) procedures so as to match efficacy to bypass procedure and nutritional status to SG procedures.
5. A recent modification referred to as single anastomosis sleeve jejunal (SAS-J) bypass is a transit bipartition procedure which has benefits of sleeve and Roux-en-Y and MGB bypass and diminished effects on nutritional deficiency. Literature review showed that SAS-J bypass has better weight loss outcome than sleeve gastrectomy and better nutritional status better than roux en Y bypass possibly.
6. From the available literature, there have been no reports of suspected, unexpected, or serious complications following SAS-J. Meanwhile, Sleeve bypass have been used as re-do procedures following SG for weight regain.
7. There is no study in literature comparing SASJ vs SG with nutritional status as the primary outcome.
8. The study by Huang C et al showed that sleeve plus (SASI, SADI and LDJB + SG) had significant better weight loss when compared to SG, MGB and Roux-en-Y; however, they had significant nutritional deficiency.
9. There are a few articles on SAS-J published in medical journals with good short term results. In a study published by Sewefy A. et al in 2021 it was observed that SASJ procedure resulted in satisfactory weight loss and better nutritional status. However, it was a retrospective cohort study, heterogeneous groups (compared to MGB, Roux-en-y and SG) with primary outcome as weight loss rather than nutritional deficiency. The authors in this study concluded that SAS-J, LSG, roux-en-Y and MGB and SADI had 85%, 59%, 56 – 72% and 60 – 84% and 91 -95% weight loss at 1 year.
10. There is no study in the English literature comparing the two treatment protocol [SAS-J versus SG] in patients with obesity with nutritional deficiency as primary outcome. Hence, this study is proposed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •BMI more than 32.5 with and without comorbidities
- •Asian population.
排除标准
- •Biopsy proven Chronic liver disease
- •Revision bariatric surgery
- •Pregnancy, lactating mother
- •Failure to comply with the post-operative protocol (dietary advises and exercise etc.)
- •Pituitary tumors or adrenal tumors
- •Long term use of anti-depressants or immunosuppressant’s including corticosteroids.
结局指标
主要结局
To compare the nutritional deficiency between two bariatric bypass surgery
时间窗: 6 months and 12 months
次要结局
- 1. Compare the % Excess Weight Loss between the two groups
研究者
Manjunath Maruti Pol
All India Institute of Medical Sciences New Delhi
