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临床试验/NCT01041456
NCT01041456已完成不适用

Another Revisional Strategy to Address Severe Late Complications After Previous Biliopancreatic Diversion for Obesity: Major Revision From Standard Biliopancreatic Diversion to Proximal Roux-en-Y Gastric Bypass

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Morbidity and mortality

研究概览

简要总结

The aim of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional GBP after either failed and/or complicated Biliopancreatic Diversion "BPD" for weight loss. With such information, we hope to determine what features might assist us in advancing our knowledge about mechanisms of failure after primary bariatric surgery, mechanism of action of revisional GBP, and performance of revisional GBP through traditional outcome measurements as well as identifying predictors of good or poor outcome after revisional GBP in this specific subpopulation.

详细描述

In Italy, Professor Nicola Scopinaro, after studies in dogs, performed the first BPD in humans in 1976. Because of the lack of blind-loop syndrome and selective malabsorption for starch and fat, the BPD has an accepted risk-benefit ratio compared to the long ago abandoned Jejunoileal Bypass (a purely malabsorptive procedure). BPD side effects after resumption of full food intake include 2 to 4 bowel movements "BM" per day of foul-smelling, soft stools with flatulence. Modification of food habits and/or administration of neomycin or metronidazole for bacterial overgrowth syndrome tend to decrease BPD side effects after the disappearance of the postcibal syndrome somewhere around the fourth postoperative month.

To optimize its performance but mainly to decrease the protein malnutrition incidence, the BPD has undergone several modifications until 1992 when the ad hoc stomach-ad hoc alimentary limb BPD configuration was implemented. Consequently, the early sporadic and late recurrent forms of protein malnutrition have decreased from as high as 30% and 10% to as low as 2.0% and 1.0%, respectively.

PROTEIN-CALORIE MALNUTRITION

I) After BPD Protein-calorie malnutrition "PCM" is multifactorial and depends on patient-related factors (such as eating habits, capacity to adapt these to requirements set by the surgery, and socio-economic status) and technical factors (including gastric volume, bowel limb lengths, intestinal absorption and adaptation, and amount of endogenous nitrogen loss). Most cases are limited to a single or sporadic episode. In the early postoperative period secondary to the forced reduced food intake, the marasmic form of PCM incidence is higher, which is the aim of the operation. However, when carbohydrate intake is preferred (poor compliance with adequate protein intake), the hypoalbuminemic form will develop. The absorptive capacity of the alimentary limb "AL" and common limb or channel "CC" depends on 1) number of villi per square centimeter, 2) transit time, and 3) total intestinal length of the AL + CC. Thus, any condition that interferes with postoperative intestinal adaptation, mainly villous hypertrophy; increased transit time; and/or decreases the length of the functional AL + CC will lead to late onset of severe PCM. Increased number of bowel movements "BM" or severe diarrhea generally precedes to PCM.

After adequate counseling with life-style changes (mainly consumption of more than 90 g/day of high biological value protein), supplementation with pancreatic enzymes, and management of contributing medical conditions (such as gastroenteritis, lactose intolerance, intestinal bacterial overgrowth syndrome, celiac sprue, and inflammatory bowel disease), recurrent or severe PCM is frequently caused by excessive malabsorption. When mild or moderate protein malnutrition is instated, two to three weeks of parenteral nutrition are generally required to revert it. In contrast, severe PCM refers to the need for prolonged total parenteral nutrition "TPN", recurrent need for TPN, or malnutrition recalcitrant to TPN. Eventually, revisional surgery is required. The recurrent or severe form of PM is rarely secondary to excessive persistence of the food limitation mechanism with or without poor protein intake, requiring restitution of the intestinal continuity or complete reconstruction of the gastrointestinal tract (partial vs. full restoration). The partial restoration of the gastrointestinal tract allows normal protein-energy absorption, still partially preserving the specific effects of BPD on glucose and cholesterol metabolism.

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

入选标准

  • Patients status post biliopancreatic diversion with any combination of the following severe late complications:
  • Metabolic and/or nutritional BPD-related complications.
  • Excessive weight loss
  • Poor weight loss, either Inadequate initial weight loss or Weight recidivism
  • Intolerable intestinal malabsorptive symptoms without severe malnutrition
  • Undergoing either open or laparoscopic conversion to Roux-en-Y gastric bypass (RYGB) surgery.

排除标准

  • Any other type of revision or conversion surgery.
  • Adequate response to medical management of metabolic and nutritional complications after previous BPD
  • missing records and/or unreachable patients with scant information for analysis

结局指标

主要结局

Morbidity and mortality

时间窗: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years

Weight loss expressed as Body Mass Index and Percentage of excess weight loss

时间窗: at 6 months, 1 year and annually thereafter for up to 8 years

次要结局

  • Trend in comorbidities(at 6 months, 1 year, and annually thereafter for up to 8 years)
  • Symptom resolution(at 6 months, 1 year, and annually thereafter for up to 8 years)
  • Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision(It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study)
  • Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome(It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study)

研究者

申办方类型
Other

研究点 (1)

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