Audit on Anemia Variation After Major Gynacological Surgery

NCT ID: NCT05280795

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-07-01

Brief Summary

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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

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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

Conditions

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Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Yossra G. Rateb

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sayed mostafa

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assuit university

Multiple Locations, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yosra Gamal

Role: CONTACT

00201146510520

Ahmed Abbas

Role: CONTACT

00201003385183

Facility Contacts

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Yossra 1st Rateb, Master

Role: primary

002 01146510520

References

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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. doi: 10.1016/S0140-6736(96)04330-9.

Reference Type BACKGROUND
PMID: 8874456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18498676 (View on PubMed)

Other Identifiers

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anemia follow up

Identifier Type: -

Identifier Source: org_study_id

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