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"Pulmonary Complications"NCT01178567

Comparison of Pulmonary Complications Related to Sleeve Gastrectomy and Gastric Banding

An observational study of "Pulmonary Complications", run by Meir Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
"Pulmonary Complications"
How many people
307 participants
Where
1 siteIsrael
Study dates
Oct 2010to Aug 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 300 sleeve gastectomy patients

Who may be able to join

  • Patients who paste surgery in Meir Hospital included with stomach ring and sleeve surgery.

Who cannot join

  • Patients who underwent other bariatric surgery in the past will excluded

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Meir MC

    Kfar Saba, Israel, 49100

Other trials in Israel

About this study

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.

Read the detailed description

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.

Keywords
laparoscopic sleeve gastrectomy, Gastrectomy, Pulmonary Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01178567
Sponsor's protocol ID
MMC10-117-10.CTIL
Status last verified
May 2013
First submitted
8 Aug 2010
Last updated
7 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of "Pulmonary Complications", run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.

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