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Ultrasonography for Nutritional Assesment in Cirrhotic Patients (RFATCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099875
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
National Liver Institute, Egypt

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

Condition or disease Intervention/treatment
Nutrition Assessment Diagnostic Test: ultrasound

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

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasonography of Rectus Femoris and Anterior Tibialis Muscles for Nutritional Assesment in Cirrhotic Patients
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Diagnostic Test: ultrasound
    Ultrasound is a type of imaging. It uses high-frequency sound waves to look at organs and structures inside the body.


Primary Outcome Measures :
  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 [ Time Frame: perioperative days 1,3,5,7 ]
    observational prospective study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cirrhotic patients child A,B
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099875


Contacts
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Contact: Amany A. Zayd, MBBCH 01014514573 amany_zayd@yahoo.com
Contact: Magdy K. Khalil, MD 01001466228 magdykhalil10@gmail.com

Locations
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Egypt
National Liver Institute Recruiting
Shibīn Al Kawm, Menoufia, Egypt, 2345
Contact: Amany A. Zayd, MBBCH    01014514573    amany_zayd@yahoo.com   
Contact: Magdy K. Khalil, MD    01001466228    magdykhalil10@gmail.com   
Sponsors and Collaborators
National Liver Institute, Egypt
Investigators
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Principal Investigator: Amany A. Zayd, MBBCH Department of Anesthesia NLI
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Responsible Party: National Liver Institute, Egypt
ClinicalTrials.gov Identifier: NCT04099875    
Other Study ID Numbers: US in cirrhosis
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: after completion of the study,we will publish the data on special nutrition Journal
Keywords provided by National Liver Institute, Egypt:
nutrition,cirrhosis