Ultrasonography for Nutritional Assesment in Cirrhotic Patients (RFATCP)

August 20, 2020 updated by: National Liver Institute, Egypt

Ultrasonography of Rectus Femoris and Anterior Tibialis Muscles for Nutritional Assesment in Cirrhotic Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

in the study, the investigator will use ultrasound to assess the nutritional state of cirrhotic patients after major abdominal surgery,The investigator aim to assess reliability of ultrasound as a bedside,non invasive tool,The investigator will enroll 72 patients for or study which is an observational study

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 2345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cirrhotic patients child A,B

Description

Inclusion Criteria:

  • hepatic patients classified as child A, B undergoing major abdominal surgery (liver resection,whipple,Splenectomy,colectomy, Common Bile Duct exploration,By pass surgery)
  • 18-60 yrs old
  • no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: perioperative days 1,3,5,7
observational prospective study
perioperative days 1,3,5,7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Liver Institute, Egypt

Investigators

  • Principal Investigator: Amany A. Zayd, MBBCH, Department of Anesthesia NLI
  • Study Director: Eman S. Ibrahim, MD, National Liver Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (ACTUAL)

September 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • US in cirrhosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

after completion of the study,we will publish the data on special nutrition Journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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