NCT05280795

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

November 20, 2021

Last Update Submit

March 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the rate of anemia after major gynecological surgery

    percentage of patients with anemia after surgery

    one month

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

any female 18 to 60 years undegoing major gynecological surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Multiple Locations, Egypt

RECRUITING

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

    PMID: 8874456BACKGROUND
  • 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.

    PMID: 18498676BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • sayed mostafa

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 20, 2021

First Posted

March 15, 2022

Study Start

December 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 1, 2023

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations