Clinical Trial: Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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 Gast

Brief Summary: 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.

Detailed Summary:

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 w
Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Morbidity and mortality [ Time Frame: 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 [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Trend in comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ]
  • Symptom resolution [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study ]


Original Secondary Outcome:

  • Trend in comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ]
  • Subjective satisfaction [ Time Frame: at the last follow-up ]
  • Symptom resolution [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ]
  • Operative time [ Time Frame: at the time of revisional surgery under study ]
  • Hospital Stay [ Time Frame: hospitalization for revisional surgery under study ]


Information By: University of California, San Francisco

Dates:
Date Received: December 26, 2009
Date Started: March 2009
Date Completion:
Last Updated: December 31, 2009
Last Verified: December 2009