Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002622230 Date of Approval: 13/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nutritional Assessment among Cirrhotic Patients
Official scientific title Nutritional Assessment among Cirrhotic Patients Undergoing Major Abdominal Surgery Using Conventional Methods versus CT Techniques.
Brief summary describing the background and objectives of the trial sarcopenia is one of the most common and frequently hidden complications in patients with cirrhosis, which negatively impact quality of life, survival, and response to stress, such as infections and perioperative complications. Numerous indirect methods have been used to quantify body composition in cirrhotic; however, most of these methods. The present study has a purpose of identifying amongst the available methods of nutritional assessment, the most sensitive and specific to malnutrition causing sarcopenia, least affected by increased water content and the has most predictive ability of post-operative complications, that helps anesthesiologists to get the best outcome for their patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied malnutrition in cirrhosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2017
Actual trial start date 01/09/2017
Anticipated date of last follow up 01/09/2018
Actual Last follow-up date 01/09/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (please state block size and whether or not the block size was variable) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group nutritional assessment preoperative once a. Weight ,height ,BMI b. Arm muscle area (triceps skin fold thickness ,mid arm circumference ) c. Hand grip strengthd 3. Both history and clinical assessment by SGA. 4. Assessment of FM, FFM, and body compartments by BIA and angle ¿ 20 Placebo
Experimental Group nutritional assessment preoperative once a- Single slice CT at level of (L1¿L2 or L2¿L3). and Mid arm CT slice 20
Control Group nutritional assessment preoperative once a. Weight ,height ,BMI b. Arm muscle area (triceps skin fold thickness ,mid arm circumference ) c. Hand grip strengthd 20 Placebo
Experimental Group nutritional assessment preoperative once a- Single slice CT at level of (L1¿L2 or L2¿L3). and Mid arm CT slice 20
Control Group nutritional assessment once preoperative a. Weight ,height ,BMI b. Arm muscle area (triceps skin fold thickness ,mid arm circumference ) c. Hand grip strengthd 20 Placebo
Experimental Group nutritional assessment once preoperative a- Single slice CT at level of (L1¿L2 or L2¿L3). and Mid arm CT slice 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 18-70 year old. 2. Operation: major abdominal surgery (e.g. Hepatic resection, hepaticojujunostomy, Whipple operation). 3. Cirrhotic patient 1. Patient's refusal. 2. Systemic malignancy, immune suppression. 3. Mal absorption syndromes (crohn¿s disease, ulcerative colitis, Short bowel syndrome). 4. Metabolic syndromes (DM, Hyperthyroidism). 5. Muscles disease (myasthenia graves, myotonia atrophica). 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/08/2017 institution board review
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shebin elkom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome a- ICU stay. b- Patient morbidity (rate of infections assist by infection predictability score (IPS), Sequential organ failure assessment score (SOFA)). post operative
Secondary Outcome Patient mortality. post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shein elkom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafar shein elkom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute yassen abdelghafar shein elkom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aya Ali El Mogy yassen abdelghafar shein elkom 12345 Egypt
Magdy Kamal Mohamed Khalil yassen abdelghafar shein elkom 12345 Egypt
Safaa Mohamed Mansour Helal yassen abdelghafar shein elkom 12345 Egypt
Naglaa Mustafa Hussein yassen abdelghafar shein elkom 12345 Egypt
Mamdouh El Sayed Lotfy, yassen abdelghafar shein elkom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya ali rexology44@yahoo.com 012345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shebin elkom 12345 Egypt
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebin elkom 12345 Egypt
Role Name Email Phone Street address
Scientific Enquiries Aya ali rexology44@yahoo.com 012345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shebin elkom 12345 Egypt assisstant lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information