Audit on Anemia Variation After Major Gynacological Surgery

Anemia Clinical Trial

Official title:

an Audit on Postoperative Variations in Anemia Treatment After Major Gynecological Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280795
• Other study ID #: anemia follow up
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Yosra Gamal
• Phone: 00201146510520
• Email: yossrarateb96[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
Egypt	Assuit university	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996 Oct 19;348(9034):1055-60. — View Citation

McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of anemia after major gynecological surgery	percentage of patients with anemia after surgery	one month