Audit on Anemia Variation After Major Gynacological Surgery

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05280795

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anemia

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 Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

the rate of anemia after major gynecological surgery [one month]
percentage of patients with anemia after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assuit university	Multiple Locations		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Study Director: sayed mostafa, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Yossra G. Rateb, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05280795

Other Study ID Numbers:

anemia follow up

First Posted:

Mar 15, 2022

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Study Results

No Results Posted as of Mar 15, 2022