ABSTRACT
A baseline examination for the surgical subjects and
their matched controls was undertaken four weeks before
surgery (Table 1).
The intervention began on the day of surgery for
surgically treated subjects and their matched controls.
Individual dates of all subsequent examinations and
questionnaires (0.5, 1, 2, 3, 4, 6, 8, 10, 15, and 20
years) for surgically treated and control subjects were
calculated based on the dates of operation. Inclusion
criteria for the interventional study were age 37 to
60 years and BMI [weight (kg)/height (m2)] of 34 kg/m2
or more for men and 38 kg/m2 or more for women. The
BMI cutoffs corresponded to an approximate doubling in
mortality rate in each gender as compared to mortality in
the BMI range 20 to 25 kg/m2 (29). Exclusion criteria,
described elsewhere (27), were minimal and were aimed at
obtaining an operable surgical group. Identical inclusion
and exclusion criteria were used for the two treatment
groups.
