Bowel Obstruction Clinical Trial
Official title:
Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008
The main goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.
The main goal of this study is to describe and analyze the trends in the incidence rate of
internal hernia presentation after different modifications of the mesenteric closure
technique after Primary Laparoscopic RYGB Surgery from 1997 to 2009.
Secondary study aims are to describe the following points 1. Clinical presentation, whether
acute (small bowel obstruction), chronic (intermittent abdominal pain), or incidental
finding -(asymptomatic); 2. Preoperative image studies. The percentage of patients that
underwent preoperative CT/contrast studies as well as the percentage of patients that had
positive, undetermined, and normal results; 3. Site of internal herniation including
transverse mesocolon, jejunal mesentery, and Peterson's space as well as single vs. multiple
internal hernias. This study along with the existing literature will allow us to formulate
preliminary clinical recommendations.
This research is in line with the most current provocative new ideas and recent high impact
publications. Most literature points towards the antecolic routing of the Roux limb to
decrease the incidence rate of internal hernia formation. However, with this study we will
demonstrate the statistically and clinically significant decrement of internal hernia
formation with the improvement of the closure technique with a retrocolic antegastric
routing of the Roux limb.
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 years.
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 percentage of these
were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of
bariatric surgery with just less than 1% of the eligible population being treated for morbid
obesity through bariatric surgery10. 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 procedure11. Thus, revisional surgery
for poor weight loss and reoperations for technical or mechanical complications will rise in
a parallel manner. RYGB is consistently considered the revisional procedure of choice for
failed restrictive procedures.
At present there are three broad categories of bariatric procedures according to its
mechanism of action 1. purely restrictive, 2. primarily restrictive with some malabsorption,
and 3. primarily malabsorptive with some restriction. Modern standard bariatric procedures
recognized by the American Society for Metabolic and Bariatric Surgery "ASMBS" include the
following 1. adjustable gastric band, 2. sleeve gastrectomy, 3. gastric bypass, 4.
biliopancreatic diversion, and 5. duodenal switch.
There are no multi center, randomized, double blinded control trials comparing the different
standard bariatric procedures. Gastric bypass is the oldest available bariatric procedure;
without any randomized controlled trials, it is considered the gold standard procedure in
the United States.
Incisional hernias occur at a higher incidence rate after open RYGB, approximately 20
percent, whereas after laparoscopic Roux-en-Y gastric bypass "RYGB", the incidence rate is
very low. Conversely, Internal hernia is a rare complication with the open approach whereas
after laparoscopic RYGB the incidence rate has been reported somewhere between 0.2 to 8.6
percent. The most accepted theory is due to decreased adhesion formation after laparoscopic
surgery compared to open surgery.
Other factors associated with a higher incidence of internal hernia formation after RYGB are
1. childbearing age with the consequent pregnancy after RYGB, 2. Roux limb routing, 3.
Closure of mesenteric and or mesocolic defects.
Although there have been no randomized controlled trials comparing different techniques of
laparoscopic RYGB, several authors have report lower rates after modifying their technique
from a retrocolic to an antecolic approach. On the other hand, others support meticulous
defect closure as the most important factor in reducing hernia formation.
The method of fixation and mesenteric closure has evolved. Initially, as with the open
approach, defects were not closed. Then, absorbable sutures were used which were changed for
interrupted non-absorbable sutures. Lastly, continuous non-absorbable material for closing
all defects was recommended by Sugerman.
Summarizing, there is no high level of evidence for recommending the best strategy to
decrease the incidence rate the potentially devastating complication of internal hernia
after laparoscopic RYGB. After reviewing the literature the trend is toward lower rates of
internal hernia formation with antecolic compared to retrocolic, and with defect closure
compared to nonclosure. There is great variation in the incidence rate among the reported
series reflecting incomplete follow-up and other factors may affect outcomes. With this
study, we will analyze the trends in the incidence rate of internal hernia formation among
different subgroups in our consecutive series of more than 7,500 laparoscopic retrocolic
RYGB with a hand-sawn gastrojejunostomy. With this consecutive series, we will confirm
reports of small series that meticulous closure technique of mesocolic/mesenteric defects
with continuous nonabsorbable material clinically and statistically decreases the formation
rate of internal hernias after laparoscopic gastric bypass.
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Observational Model: Cohort, Time Perspective: Retrospective
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