Protein Malnutrition Clinical Trial
Official title:
One-stage Laparoscopic Revision of Failed and/or Complicated Jejunoileal Bypass to Roux-en-Y Gastric Bypass
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.
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.
Transitory resolution of most symptoms caused by the bacterial overgrowth syndrome is
accomplished by the administration, in divided doses, of oral tetracycline (2.0 g per day),
amoxicillin-clavulanate (1 to 1.7g per day), clindamycin (0.9 to 1.8 g per day), and
metronidazole (1 to 1.5 g per day) among others. Rapid symptomatic improvement is observed,
however, over time, organisms become resistant to the systemic absorption of antibiotics,
ceasing the benefit of this therapy. In addition, side effects including superinfections
such as pseudomembranous colitis might present. Local instillation of antibiotic through an
intestinal indwelling catheter placed in the excluded bowel limb has been described.
When the JIB related complications present as intractable, severe or recurrent, surgical
intervention is required. Liver, either acute liver failure or cirrhosis, (secondary to
"PCM" and bacterial overgrowth syndrome) and kidney, either tubulointerstitial nephropathy
or renoureteral lithiasis, (secondary to enteric hyperoxaluria and volume depletion)
dysfunction are the most frequently described complications leading to death. However, after
end stage liver (cirrhosis) and renal diseases are established, good judgment is needed to
assess the risk benefit algorithm for operative intervention, as these conditions are
irreversible.
In the United States, the most popular type of intestinal bypass performed was the so called
"14 plus 4" with an end to side jejunoileostomy, a 14 inches biliopancreatic limb with a 4
inches common channel. Because of poor weight loss, some surgeons used to performed an end
to end jejunoileostomy avoiding chyme to reflux into the defunctionalized limb; Through an
ileocolostomy, the defunctionalized jejunoileal limb was drained into the cecum or sigmoid
colon.
Open reversal or conversion to gastric bypass has been shown to be effective procedures with
defined complications. Since the 60s Payne, DeWind and Commons had already demonstrated that
takedown and restitution of the gastrointestinal continuity is an effective strategy to
solve the metabolic complications. However, relapse of obesity along with its comorbidities
is the rule.
Series from the 70s and 80s suggested that one stage open revision of JIB to gastric bypass
was feasible and safe. However, most of these revisions were performed a couple of years
after the original bariatric surgery with a completely different configuration (non divided
horizontal pouch with a loop gastrojejunostomy) from how modern RYGB is performed in these
days. Hence, outcome analysis of those series is not transferable in today context.
Because of the long interval time between the JIB and the revision surgery, bowel adaptation
is maximal causing a marked discrepancy in the lumen diameter and bowel thickness between
the functional and defunctionalized bowel segments. Thus, different approaches have been
described in the literature to deal with more extensive intestinal changes..
Based on Cannova et al. report in which described the placement of an intestinal indwelling
catheter in the excluded bowel limb, Dallal et al. with a minimally invasive approach
established enteral nutritional support in the defunctionalized bowel limb, to revert its
atrophy. After a three month period with extensive counseling to undergo conversion to a
RYGB, the patient decided just to be reversed.
Another staged option for revising the JIB is as follows. Initially, the JIB is dismantled
and the normal gastrointestinal continuity restored. After the initially bypassed and
atrophied small bowel regains its function and the bowel atrophy is partially overturned,
the second stage (weight loss procedure) is performed, so weight loss can be maintained or
achieved.
The two accepted revisionary procedures described in the literature for failed JIB are
mainly adjustable gastric banding (AGB) and gastric bypass. In 2000, O'Brien et al. reported
a series of 50 revisions to adjustable gastric banding. As the primary bariatric procedure,
two patients had a JIB. A one stage open revision was performed without providing specific
subset outcome analysis.
In 1993, Behrns et al. reported the outcome analysis of 61 open assorted revision surgeries
from which 14 had a JIB. The indication for this subgroup was due to severe metabolic
complications with a pre-revisional mean BMI of 34.2 kilograms per squared meter. Nine
patients were revised to VBG and five patients to a non-divided, vertical RYGB. The percent
excess weight loss for this five patients was 49.5 percent (overall follow-up was 23 months)
with a 67 percent dissatisfaction rate of their new lifestyle because of the change in
eating patterns caused by switching from a full size meal to a restricted diet.
In 1996, Owens et al. reported the open surgical revision of 75 patients from which 23
patients had a JIB as their primary procedure. Specific subgroup analysis was not provided.
In 2005, khaitan et al. reported 37 patients who underwent 39 bariatric revisions, either
open or laparoscopic. Originally, five had a JI bypass from which two were initially
approached laparoscopically. However, specific subgroup analysis was not provided.
In summary, there are just two manuscripts reporting cases of attempted laparoscopic
conversion of JIB to RYGB with its modern anatomical construction. However, a one stage
procedure has not been achieved up to date. Therefore, no outcomes with this approach have
been documented as well. With this study, we will advance our knowledge about revision
bariatric surgery and report excellent outcomes after conversion from a completely
malabsorptive procedure to a mostly restrictive weight loss procedure, the gastric bypass
and although JIB was abandoned long time ago, there are still living patients with this
procedure and bariatric surgeons need to be aware of side effects and minimally invasive
strategies for the management of these highly complex patients.
;
Observational Model: Cohort, Time Perspective: Retrospective
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