Audit on Anemia Variation After Major Gynacological Surgery | NCT05280795

Studies
Audit on Anemia Variation After Major Gynacological Surgery

NCT05280795

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 15, 2022Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Anemia

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Nov 20, 2021

First Submission Date that Met QC Criteria

Mar 4, 2022

First Posted Date

Mar 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2022

Last Update Posted Date

Mar 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the rate of anemia after major gynecological surgery	percentage of patients with anemia after surgery	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

any female 18 to 60 years undegoing major gynecological surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yosra Gamal	Contact	00201146510520		yossrarateb96@gmail.com
Ahmed Abbas	Contact	00201003385183		bmr90@hotmail.com

Overall Officials

Name	Affiliation	Role
sayed mostafa	Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assuit university	Recruiting	Multiple Locations			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8874456	Background	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.
18498676	Background	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.

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases