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.: PACTR201508001173115 Date of Approval: 16/06/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title preoperative sugar improves outcome
Official scientific title preoperative carbohydrate loading in laparoscopic cholecystectomy
Brief summary describing the background and objectives of the trial oral intake of carbohydrate solutions until 2 h before the surgery has been introduced to prevent unfavorable problems caused by dehydratation and hunger.study will investigate effect of preoperative carbohydrate loading on post operative nausea and vomiting, post operative analgesic requirements, hunger, anxiety, sleep quality and inflammatory markers as C reactive protein. study also also investigated effect of carbohydrate loading on intraoperative and post operative hemodynamics and gastric residual volume.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied preoperative,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 29/08/2016
Actual trial start date 10/09/2016
Anticipated date of last follow up 29/12/2016
Actual Last follow-up date 31/12/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group preoperative carbohydrate loading 200 ml carbohydrate formula 2 hours preoperative 20
Control Group preoperative fasting nothing per os 6 hours pure preoperative fasting 20 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all patients candidate for laparoscopic cholecystectomy aged 18-70 years BMI more than 30 diabetes mellitus 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 26/09/2016 IRB mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
gomhuria mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative nausea and vomiting in post anesthesia care unit post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gastroenterology surgical centre Gihan street mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura faculty of medicine gomhuria street mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor usama elsayed elkods elsharief mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hossam hamed Gihan street mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator usama mohammed usamaelsayed20@yahoo.com 01028842265 elkods elsharief
City Postal code Country Position/Affiliation
mansoura Egypt lecturer
Role Name Email Phone Street address
Public Enquiries hossam hamed hossamhamed@yahoo.com 01028842244 obour street
City Postal code Country Position/Affiliation
mansoura 44444 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries refaey kandeel refaey2@yahoo.com 01028842255 obour street
City Postal code Country Position/Affiliation
mansoura 44444 Egypt lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information