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Surgery - Studies - ASERNIP |
News 27
June 2000
This
site is not meant to replace your Doctor's advice. The advice on this
site is from other wls patients and may not be relevent in your case or
even harmful. |
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ASERNIP-S
is a pilot project, funded by the Federal Government through the Department
of Health and Family Services for a three-year period. The project is administered
by the Royal Australasian College of Surgeons and began operating in January
1998. The recommendations of the Australian Health Technology Advisory Committee’s
Review of Minimal Access Surgery addressed the need for establishment of
a body to assess new surgical procedures and technologies. ASERNIP-S emanated
from this recommendation. The broad aims of the project lie in three areas. To establish a mechanism for collecting, collating and analysing data concerning the safety and efficacy of selected new surgical procedures. To make recommendations on whether the procedure should be used with or without continuing audit, or if a more fully controlled evaluation is necessary. To disseminate the information to fellows and trainees of the College through CME and training programs, to credentialling committees, practitioners, consumers, health care providers and government agencies. ASERNIP-S recently finished assessing the Laparoscopic Adjustable Gastric Banding for the Treatment of Obesity. Executive Summary Laparoscopic Adjustable Gastric Banding Background: The aim of this systematic review was to assess the safety and efficacy of laparoscopic adjustable gastric banding for the treatment of obesity. Methods: Search Strategy - Two search strategies were devised to retrieve literature from the Medline, Current Contents, Embase and Cochrane Library databases up until February 2000. Study Selection - Inclusion of papers was decided using a pre-determined protocol which specified suitable studies by type of participants, comparators, outcomes, and type of study. English language papers were selected. Acceptable study designs included randomised-controlled trials, controlled clinical trials, case series or case reports. Data Collection and Analysis - Thirty-seven papers met the inclusion criteria. They were tabulated and critically appraised in terms of methodology and design, outcomes, and the possible influence of bias, confounding and chance. Results: There was little high level evidence available and few comparative studies. Safety: Mortality rates were less than 1 in 1000, which is less than that quoted in many reviews of other surgical procedures for the treatment of obesity. Likewise, morbidity rates did not appear to exceed those quoted for other procedures. Efficacy: Most operations appear to be completed in under 2 hours. Most studies reported rates of conversion to open procedures of under 4%. Patients appear to be discharged earlier than those undergoing vertical banded gastroplasty, and also appear to become more mobile and independent after surgery, although initially positive responses to the surgery tend to diminish with time. The laparoscopic adjustable gastric band appears capable of producing substantial weight loss up to 4 years, although longer term data has not been published and the consistency of weight loss across the patient population is also unclear due to poor reporting of variance in most studies. Safety and Efficacy Classification: The ASERNIP-S review group recommended a classification of 2; namely, the safety and/or efficacy of the procedure cannot be determined at the present time due to an incomplete and/or poor quality evidence-base. It is recommended that further research be conducted to establish safety and/or efficacy. Specifically, it is recommended that a register of adjustable bands and a record of serious complications be established, possibly with anonymous reporting. The manufacturers of the adjustable bands should be encouraged to participate. Review Group Membership: Advisory Surgeon: Mr Philip Game Protocol Surgeon: Mr George Kiroff Other Specialty Surgeon: Mr Bruce Foster Nominated Surgeon: Professor Paul O'Brien Invited Surgeon: Professor John Ham ASERNIP-S Director: Professor Guy Maddern ASERNIP-S Researcher: Mr Andrew Chapman You can download the full document (approx 70 pages) by clicking on the two following links.
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