One-stage Laparoscopic Revision of Failed and/or Complicated Jejunoileal Bypass to Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Remission or improvement of symptoms and JIB-related complications
研究概览
简要总结
This study objectives are the following.
- To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB).
- To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss.
- To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.
详细描述
The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30 to 40 percent), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years8.
Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery "ASMBS" reported that 81 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percent of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1 percent of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20 percent of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.
Regardless of being an effective treatment of morbid obesity, JIB was abandoned in the early 80s mostly because of its metabolic and nutritional complications. Multiple patients who underwent this procedure more than two decades ago are still alive. Close follow-up, in even asymptomatic patients, is necessary after JIB because they may present with nonreversible complications.
As with any bariatric procedure, weight regain, inadequate initial weight loss, and late complications or a combination of them are the most widely accepted indications to undergo revisional bariatric surgery. Specifically, the JIB related late complications can be arbitrarily categorized into "malabsorption and malnutrition" and "bacterial overgrowth syndrome". The former might present with steatorrhea, electrolyte (K, Ca, P, Mg) and acid base imbalance (hyperchloremic metabolic acidosis), liposoluble (A, D, E, K) and hydrosoluble (B1, B12 and Folate) vitamin deficiencies, and protein calorie malnutrition "PCM". "The bacterial overgrowth syndrome" causes a variety of complications such as gas bloat syndrome, foul smelling flatulence, recurrent migratory polyarthralgia and necrotizing skin lesions. Other late non metabolic complications related to the bypassed bowel include intussusception, pseudo-obstruction, and bypass enteropathy.
"PCM" is quickly and effectively treated by parenteral nutritional support. Diet optimization with consumption of high biological value protein (90 g per day) and a total calorie intake adjusted to ideal body weight might decrease the severity of the malabsorption syndrome and or prevent its recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met NIH criteria for weight loss surgery with poor weight loss after JIB
- •Intractable, severe and/or recurrent JIB-related late complications after optimized medical management
- •Laparoscopic approach for primary revisional bariatric surgery
排除标准
- •Any other type of revisional bariatric procedure
- •Open approach for revision surgery
- •missing records and/or unreachable patients with scant information for analysis
结局指标
主要结局
Remission or improvement of symptoms and JIB-related complications
时间窗: throughout follow-up
Morbidity and mortality
时间窗: throughout follow-up
Remission or improvement of other comorbidities
时间窗: throughout follow-up
Weight loss expressed as Body Mass Index and Percentage excess weight loss
时间窗: throughout follow-up
次要结局
- Operative time(transoperatively)
- conversion to open approach(transoperatively)
- Hospital stay(same hospitalization)
