Status
Conditions
Study type
Funder types
Identifiers
About
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.
Full description
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.
II) After RYGB
After extensive review of the literature, Kushner listed principal variables that contributed to nutritional deterioration after bariatric surgery: 1) sever malabsorption after malabsorptive procedures such as BPD or BPD-DS and distal or very, very long-limb RYGB; 2) surgical mechanical complications, such as stenosis at the gastrojejunostomy, intractable marginal ulcer, and gastro-gastric fistula; and 3) Non-compliance
Same analysis and review of the literature is available but less extensive for Metabolic bone disease, Anemia (Iron, folate, and vitamin B12), liposoluble vitamins and essential fatty acids.
Revisional strategies:
Revisional strategies that have been described for long-term complications after BPD are 1) elongation of common limb or channel, 2) restoration of intestinal continuity (partial restoration), and 3) restoration of gastrointestinal continuity (full restoration).
RYGB vs. BPD: Roux-en-Y configuration
Weight maintenance after BPD or BPD-DS appears to be superior to that after restrictive procedures and RYGB. However, this has never been subjected to a randomized controlled trial.
Intuitively, one would expect macro and micronutrient deficiency after bariatric surgery to be more frequent and severe when primarily malabsorptive with some restriction or pure malabsorptive procedures have been carried out, and this has been shown to be correct (level of evidence 3 or C).
Comparing the incidence rate of the largest series performed by experts, the incidence rate of late metabolic/nutritional complications after standard BPD/BPD-DS is higher than after standard RYGB.
There are trials with a level of evidence 3 & 4 (C & D) that favor the overall superiority of RYGB over BPD for clinically severe obesity including among others the following:
Summarizing, there is no evidence level A or 1 about what is the best overall primary bariatric procedure to address obesity at the long-term. In the USA, most investigators prefer RYGB for primary bariatric procedure, leaving BPD or BPD-DS for select cases including revisionary surgery for poor weight loss. After RYGB and BPD/BPD-DS, patients require to give priority for protein intake over other macronutrients as well as vitamin and mineral supplementation lifelong; there is no objective and standardized recommendation for supplementation. However, when metabolic/nutritional complications after BPD or BPD-DS develops regardless of optimized multispecialty medical management, lengthening of the common channel and partial or full reversals have been described. On the other hand, one-stage revision, either open or laparoscopic, from BPD to standard RYGB has never been reported. With this study, we will advance our knowledge about revisional RYGB, metabolic complications after hybrid bariatric procedures, and along with the existing literature, we will draw preliminary clinical recommendations.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients status post biliopancreatic diversion with any combination of the following severe late complications:
Undergoing either open or laparoscopic conversion to Roux-en-Y gastric bypass (RYGB) surgery.
Exclusion criteria
10 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal