Audit on Anemia Variation After Major Gynacological Surgery

• Conditions: Anemia

• Registration Number: NCT05280795
• Lead Sponsor: Assiut University

Brief Summary

The study aims to increase our understanding of variability in adherence to anaemia management guidelines and to assess the impact of anaemia management in clinical care following major gynaecological surgery

Detailed Description

Anemia affects nearly a quarter of the world and is common in surgical patients with a third of patients presenting with preoperative anemia and three quarters of patients discharged from hospital with anemia. The World Health Organization defines anemia as an insufficient circulating red cell mass, with haemoglobin (Hb) concentration of \< 130 g.l-1 for men and \< 120 g.l-1 for women .

Perioperative anemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogeneic blood transfusions, which is an independent risk for poorer patient outcomes.

Postoperative anemia can be due to blood loss at operation or secondary to the inflammatory process associated with surgery, which causes an increase in hepcidin production resulting in functional iron deficiency and reduced red cell production.

In recent years, there has been a significant increase in the use of intravenous iron therapy for preoperative anemia in line with major international guidelines

Study Timeline

• Study First Submitted: 2021-11-20
• Study Start: 2021-12-01
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-04
• Last Update Submitted: 2022-03-04
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-06-30
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Age: Adult, 18_60 years
• Procedure: A major gynecological surgery is defined as an operation with an incision into the abdominal cavity and anticipated duration of more than one hour. Procedures performed using any surgical approach, including open and laparoscopic surgery are included.
• Urgency: Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery

Exclusion Criteria

• Procedures: surgery classified as minor operations such as; diagnostic laparoscopy (emergency or elective), D&C.
• Indication: Palliative procedures as determined pre-operatively and explicitly stated in the medical record or consent form.
• Return to theatre: Each patient should only be included in the study once. Patients returning to theatre due to complications following earlier surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the rate of anemia after major gynecological surgery	one month	percentage of patients with anemia after surgery

Trial Locations

Locations (1)

Assuit university; 🇪🇬 Multiple Locations, Egypt