NCT04099875

Brief Summary

Ultrasonography of Rectus Femoris and Anterior Tibialis muscles for nutritional assesment in cirrhotic patients undergoing major abdominal 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
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

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

Study Start

First participant enrolled

April 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

April 24, 2019

Last Update Submit

August 20, 2020

Conditions

Nutrition Assessment

Keywords

nutrition,cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Measurement of the diameters of the Rectus Femoris and Anterior Tibialis muscles using the ultrasound in cm and the change of these diameters over the postoperative period till the 7th day to assess nutrition status in cirrhotic patients

    observational prospective study

    perioperative days 1,3,5,7

Interventions

ultrasoundDIAGNOSTIC_TEST

Ultrasound is a type of imaging. It uses high-frequency sound waves to look at organs and structures inside the body.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

cirrhotic patients child A,B

You may qualify if:

  • hepatic patients classified as child A, B undergoing major abdominal surgery (liver resection,whipple,Splenectomy,colectomy, Common Bile Duct exploration,By pass surgery)
  • yrs old
  • no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization

You may not qualify if:

  • Refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or COPD)
  • previous immune abnormalities including treatment with corticosteroids
  • neuromuscular diseases
  • laparoscopic surgery
  • patients on parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Liver Institute

Shibīn al Kawm, Menoufia, 2345, Egypt

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Amany A. Zayd, MBBCH

    Department of Anesthesia NLI

    PRINCIPAL INVESTIGATOR

  • Eman S. Ibrahim, MD

    National Liver Institute

    STUDY DIRECTOR

Central Study Contacts

Amany A. Zayd, MBBCH

CONTACT

01014514573amany_zayd@yahoo.com

Eman S. Ibrahim, MD

CONTACT

01016303518emansayed825@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

September 23, 2019

Study Start

April 1, 2019

Primary Completion

July 1, 2020

Study Completion

April 1, 2021

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

EG(1)