Impact of Preoperative Anemia on Healthcare Outcomes

NCT03497416 | Unknown

• 1 other identifier: PANAMA
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

Preoperative Anemia; elderly; healthcare outcomes

Outcome Measures

Primary Outcomes (1)

• Preoperative anemia and morbidity

  To determine the association between preoperative anemia and morbidity at the 5th postoperative day (POD) as indicated by presence of any Post-Operative Morbidity Survey (POMS) defined complications.

  5 days from surgery

Secondary Outcomes (3)

• Preoperative anemia and 30-day morbidity using POMS

  1 month from index surgery

• Preoperative anemia and 30-day morbidity using Comprehensive Complication Index

  1 month from index surgery

• Preoperative anemia and mortality

  1 month from index surgery

Other Outcomes (1)

• Preoperative anemia and patient's health related quality of life (HRQoL)

  1,3 and 6 months from index surgery

Study Arms (2)

Anemic

Other: No intervention

Non-anemic

Other: No intervention

Interventions

No intervention OTHER

No intervention

Anemic; Non-anemic

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly at least 65 years of age who are undergoing elective major abdominal surgery

You may qualify if:

• At least 65 years of age and signed written informed consent.
• Patients undergoing elective major open abdominal surgery for benign or malignant disease.

You may not qualify if:

• Transplantations (specifically patients who are admitted to the hospital for a transplantation and has a transplantation procedure and any additional surgical procedure during the hospitalisation will be excluded; any operation done after the patient has been discharged from the transplantation stay will be included)
• Inability to comprehend and/or perform study procedures in the investigator's opinion.

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 62223322, Singapore

RECRUITING

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hairil R Abdullah, MMed

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Tan Clinical Research Coordinator

CONTACT

006563265428; brenda.tan.p.y@sgh.com.sg

Thin Thiri Naing Research Nurse

CONTACT

006563265428; thin.thiri.naing@sgh.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 13, 2018
• Study Start: October 3, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)