Anemia Clinical Trial
Official title:
Preoperative Anemia Among the Elderly Undergoing Major Abdominal Surgery: Impact on Healthcare Outcomes
Preoperative anemia is a known risk factor for morbidity, mortality and increased healthcare
resource utilisation. The Investigator's previous study demonstrated the rate of preoperative
anemia in Singapore General Hospital (SGH) to be at 26.6%. The rate is highest in the elderly
group which stands at 49.9%. The main objective of this study is to investigate the
perioperative morbidity and mortality, blood transfusion rate, healthcare outcomes and
patient-centric outcomes among anemic elderly patients undergoing major surgery. The
investigators hypothesize that elderly patients who undergoes major abdominal surgery with
preoperative anemia will have higher composite morbidity and mortality rates (primary
outcome), longer length of hospital stay, higher blood transfusion requirements and lower
health-related quality of life (HRQoL) at 1, 3 and 6 months (secondary outcomes) when
compared to elderly patients without preoperative anemia. The investigators will conduct a
prospective observational study of 450 consecutive patients above 65 years, who are
undergoing elective major open abdominal surgery in SGH over 12 months. Baseline clinical
assessment, including iron studies for anemic patients, will be done within 14 days prior to
surgery. To determine the primary outcome, patients will be followed up prospectively for 30
days from the day of surgery. This will be done via a mixture of medical records review and
phone interview. For secondary outcomes, the length of hospital stay and readmissions for any
reason within 3 and 6 months will be recorded.
HRQoL questionnaires will be done through phone calls by a study team member. Findings from
this study will hopefully fill the knowledge gaps such as how anemia impacts elderly people
in terms of perioperative morbidity, mortality, postsurgical quality of life and their
eventual return to the community as well as providing local data on the healthcare resource
utilisation in this group.
Preoperative anemia is a common and important problem in the elderly.
Many studies have established association between preoperative anemia and poor postoperative
outcomes. Some propose that preoperative anemia is an independent risk factor of adverse
outcomes. Preoperative anemia is also one of the strongest predictors of perioperative blood
transfusion which is independently associated with increased risk of perioperative morbidity
and mortality. Consequently, preoperative anemia increases healthcare utilization and costs
due to increased blood transfusion requirements, prolonged length of hospital stay and
hospital readmission rates. As more elderly patients undergo surgery yearly, there is a need
to improve perioperative outcome, contain healthcare costs and help rapid return to
community. Addressing preoperative anemia could be one such strategy as it may lead to
decreased need for blood transfusion, and reduction of morbidity and mortality, and improved
health-related quality of life. The relationship between anemia and quality of life is well
documented in patients with cancer and with end-stage renal failure, but not so well examined
in elderly postoperative patients.
The primary aim of this study is to investigate the impact of preoperative anemia on
postoperative complications as defined by presence of Postoperative Morbidity Survey (POMS)
defined complications at day 5. The 9 domains within POMS allow classification of
complications into various organ categories, such as cardiac, respiratory, infectious etc.
The secondary aim of this study is to investigate the impact of preoperative anemia on the
severity of post operative complications as classified with the Clavien Dindo Classification
and Comprehensive Complication Index.
Other secondary aims of this study include investigating the association between preoperative
anemia and length of hospital stay, readmission within 6 months, days alive and out of
hospital (DaOH) within 6 months, and 30-day mortality. Data generated on the potential
healthcare costs of this modifiable risk factor would help to provide the background for
future studies on intervention strategies and its cost effectiveness.
Another secondary aim of the study is to examine the relationship between preoperative anemia
and baseline and postoperative health-related quality of life indices up to 6 months
postoperative using the EQ-5D questionnaire. The results of this study will encourage
policies that risk profile patients who may require extra support on returning to the
community. In the longer term, the investigators hope to spur studies which look at the
optimal hemoglobin level prior to hospital discharge after surgery.
Significance of the Study
The findings from this study will have a significant impact on the way clinicians and
researchers approach preoperative anemia in the elderly. The full clinical, patient-centred,
and economic impact of operating on an anemic elderly patient has not been clearly
elucidated, especially in the local context. In the longer term, this study may set the
foundation for nationwide policies to address anemia in the surgical population with the aim
of improving patient outcomes in the most cost effective manner.
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