Clinically Severe Obesity Clinical Trial
Official title:
Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass
The main aim of this study is to analyze and report the preliminary and intermediate term
outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.
The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and
expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3)
Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized,
non-validated subjective satisfaction questionnaire and the validated, disease-specific,
Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including
nutritional status and metabolic complications.
Consequently, secondary objectives of this study are 1) to assess failure rate defined as
percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for
superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point
in time when assessing preliminary and intermediate results after the surgery under
analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular
clinical and biochemical parameters.
This research is in line with the most current provocative new ideas and recent high impact
publications. To the best of our knowledge, this is the very first outcome study of
revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse
revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional
Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb
gastric bypass. Previously, several studies have addressed conversion to malabsorptive
gastric bypass after a failed primary proximal gastric bypass but none has addressed the
failed distal gastric bypass nor the adequate balance between increasing restriction and
malabsorption for decreasing the risk of protein-calorie malnutrition.
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% of
bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had
bariatric surgery in the United States from which approximately 80% 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 surgery. Along with the increasing number of elective primary weight loss
procedures, up to 20% 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 re-operations 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.
In general, there is a lack of long-term (5-10 years) and very long-term (> 10 years)
outcome studies for modern bariatric surgery that would allow us to better define the role
of each one of these procedures, especially after the advent of the laparoscopic approach.
In an animal model, diet induced obese animals exhibiting metabolic syndrome underwent
Roux-en-Y gastric bypass with highly reproducible surgical outcomes as well as biochemical
and energetic homeostatic abnormalities similar to post-RYGB findings in humans. Weight
regain occurs in approximately 20% of patients after two to three years after RYGB. It seems
that the weight-loss-promoting effects of chronically elevated plasma PYY concentrations
dominate the weight-gain-promoting effects of lowered plasma leptin concentrations, with the
relative plasma PYY: leptin concentration ratio determining whether weight loss will be
sustained or regained.
Several studies have compared different Roux limb lengths in primary bariatric surgery. It
seems to be that long limb RYGB (150cm), especially in patients with BMI > 50 kg/m2, confers
at least better short-term weight loss without nutritional consequences. Conversely, other
investigators have not found any clinically significant difference in weight loss with
increasing Roux limb lengths, especially in patients with BMI < 50 kg/m2 23-26. The
following are the main investigators that have increased the malabsorptive component of the
failed proximal gastric bypass as a revisional strategy:
1. Torres JC in 1991 was the first to propose this strategy with a cohort of 140 patients
followed for 5 years (90.5% follow-up rate). Analyzed traditional outcome measures were
early (2.1%) and late (27%) morbidity including protein-calorie malnutrition (7%); %EWL
at 1,2,3,4,and 5 years were 89.5%, 91%, 87%, 82.5%, 82.5%, respectively; and
re-operations.
2. Fox SR and Oh KH et al in 1996 reported 10 failed proximal gastric bypass patients
undergoing distal gastric bypass from an diverse group of failed primary surgeries
(n=80) followed for 3 years with a 92.5% follow-up rate. Reported traditional outcome
measures were early (39%) and late (84%) morbidity; %EWL at 1,2,&3 years was 83%,
89%and 94%, respectively; high satisfaction was also reported.
3. Sugerman et al in 1997 published their outcomes with 27 patients. Five patients were
converted to a malabsortive distal gastric bypass with a 50cm common channel which
required a second revision for malnutrition and two died. 22 patients were revised to a
150cm common channel; three patients required a second revision for malnutrition but
%EWL went from 30% to 61% at 1 year and 69% at 5 years. They concluded that a 50cm
common channel had an unacceptable morbidity and mortality.
4. Fobi et al in 2000 presented his results of 65 patients after mostly failed primary
Fobi pouch operation. 15 patients developed protein calorie malnutrition requiring
supplemental nutrition and 6 required further revision.
5. The 2001 Sapala´s et al partial outcome analysis on 303 varied revisionary micropouch
gastric bypass procedures with a 200cm Roux limb, 150cm biliopancreatic limb and >200cm
common channel. %EWL during 3 years is similar to the primary procedure (68.6%, 76.6%,
and 72.3%). However no subset analysis is performed.
6. Pareja et al analysis of 41 patients, undergoing diverse distal malabsorptive
techniques, included 32 revisionary procedures after primary Fobi-Capella gastric
bypass. At 11, 16, and 19 months of mean follow-up, %EWL for the Scopinaro-style,
Brolin, and Fobi revisionary gastric bypasses were 69.7%, 65.0%, 74.8%, respectively.
Failure and success rates according to Biron et al. are provided but no other subgroup
analysis is provided.
7. Brolin et al on 2007 reported 47 out of 54 patients undergoing revision for failed
primary bariatric surgery had a very, very long limb gastric bypass with a 75cm to
100cm common channel and a 15cm to 25cm biliopancreatic limb. 7.4% (n=4) developed
protein-calorie malnutrition from which one required 6 weeks of TPN, two elongation of
the common channel (150cm) and one reversal after a prolonged hiatus returning with
severe metabolic complications. 47.9% of the series lost at least 50% EWL at 1 year.
There was no difference between those with primary failed restrictive vs. primary
failed gastric bypass patients.
8. Sarr et al on 2007 states that "patients with anatomically intact, non-malabsorptive
RYGB when converted to a malabsortive distal RYGB, good results are not common".
To the best of our knowledge and after extensive literature search, there is no outcome
study employing a laparoscopic approach for revisional malabsorptive distal Roux-en-Y
gastric bypass specially increasing the restrictive component in a failed primary
malabsorptive distal type of gastric bypass. Thus, we decided to analyze our own series
including the learning curve and diverse revisional techniques in this unique subset of
patients: 1) revision gastroplasty; 2) Fobi-Capella (static band); 3) Adjustable gastric
band; 4) Conversion to either modality of malabsorptive distal gastric bypass, very, very
long limb or distal.
Summarizing, there is lack of very-long term outcomes after bariatric surgery and
standardization of gastric bypass surgery. The treatment of inadequate weight loss or weight
recidivism after Roux-en-Y gastric bypass (RYGB) remains refractory to medical treatment.
Failure rates have been reported up to 20% and 35% for the morbidly obese and super obese,
respectively at 2 to 3 years after surgery. The indication for further surgical intervention
remains controversial, as does what type of procedure to recommend. Furthermore, there is no
standardization of the limb lengths, pouch size or the use of prosthetic reinforcement.
Therefore the approach to these patients must be as individualized as their original
operations. We analyze our experience with the laparoscopic approach to these complex and
challenging patients.
;
Observational Model: Cohort, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01040572 -
Laparoscopic Revision Gastric Bypass for Weight Recidivism
|
N/A | |
| Completed |
NCT01041131 -
Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass
|
N/A | |
| Completed |
NCT01040507 -
Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass
|
N/A | |
| Completed |
NCT01041105 -
Gastric Bypass After Previous Anti-reflux Surgery
|
N/A | |
| Completed |
NCT01040533 -
Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass
|
N/A |