Pulmonary Complications Clinical Trial
Official title:
Comparison of Pulmonary Complications Related to Laparoscopic Sleeve Gastrectomy and Laparoscopic Adjustable Gastric Banding
Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding.
Obesity is defined as a body mass index (BMI) of more than 30 (1). Its frequency varies
according to social, economical and cultural situations. Approximately 15%-20% of the
population of Europe, 40% of the United States, and up to 80% of some Native American and
Pacific Islands populations (1) are morbidly obese, defined as a BMI more than 39 (2).
The laparoscopic adjustable silicone banding (LAP-BAND) procedure has rapidly gained
acceptance and is now considered the most common bariatric operation. In the literature,
there are rare case reports about respiratory complications following LAP-BAND. Hofer et al.
(3) reported a case of recurrent aspiration pneumonia. Nemni reported a case of chronic
cough that was eliminated after LAP-BAND deflation (4). Almoudi reported a case of left
lower lobe pneumonia 3 years following LAP-BAND. The patient had presented with asthma-like
symptoms (5).
However, there are no studies in the literature addressing long-term pulmonary complications
following LAP-BAND. Reports on most previous studies with a medium-term follow-up of 4 years
have focused on weight loss as a deciding factor for the success of the surgery, rather than
on long-term complications.
Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management
of morbid obesity (6). Early data suggest LSG is efficacious in the management of morbid
obesity and may have an important role either as a staged or definitive procedure. A
systematic review of the literature analyzing the clinical and operational outcomes of LSG
was completed to further define the status of LSG as an emerging treatment modality for
morbid obesity (7). Data from LSG were compared to benchmark clinical data and local
operational data from laparoscopic adjustable gastric band (LAP-BAND) and laparoscopic
gastric bypass (LRYGB) procedures.
A systematic review of the literature identified 15 studies (940 patients). The percent
excessive weight loss (%EWL) for LSG varied from 33% to 90% and appeared to be sustained up
to 3 years. The mortality rate was 0-3.3% and major complications ranged from 0% to 29%
(average 12.1%). Operative time ranged from 49 to 143 min (average 100.4 min). Hospital stay
varied from 1.9 to 8 days (average 4.4 days).
The operational impact of LSG has not been described in the literature. Early,
non-randomized data suggest that LSG is efficacious in the surgical management of morbid
obesity (8). However, it is not clear if weight loss following LSG is sustained long term
and therefore, it is not possible to determine what percentage of patients may require
additional revisional surgery following LSG. The operational impact of LSG as a staged or
definitive procedure is poorly defined and must be analyzed further to establish its overall
health care costs and operational impact. Although LSG is a promising treatment option for
patients with morbid obesity, its role remains undefined and it should be considered an
investigational procedure that may require revision in a subset of patients (9).
Although previous studies reported that both LSG and LAP-BAND resulted in postoperative
improvement or resolution of comorbid conditions associated with obesity, LSG statistically
showed a significantly higher rate of resolution or improvement of DM, HTN, and LPD. There
was no significant difference between the groups for DJD, GERD, OSA, or asthma (2). The
incidence of pulmonary complications was not reported.
This study will retrospectively compare the rates of pulmonary complications following
LAP-BAND and LSG surgeries. The effect of the surgery on the comorbid conditions of type 2
diabetes mellitus (DM), hypertension (HTN), hyperlipidemia (LPD), degenerative joint disease
(DJD), gastroesophageal reflux disease (GERD), obstructive sleep apnea (OSA), and asthma in
the two subpopulations will also be assessed.
;
Observational Model: Cohort, Time Perspective: Retrospective
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