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.: PACTR201806003372989 Date of Approval: 04/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ultrasound guided ERAS
Official scientific title Ultrasound guided enhanced recovery program in colorectal surgery: Kasr Alainy modified protocol
Brief summary describing the background and objectives of the trial Enhanced recovery program in colorectal surgery (ERAS) had become the standard of care in many centers, It improved the postoperative hospital stay, and patient satisfaction, however there was still some drawback like postoperative nausea and vomiting and increase in readmission rate. The purpose of this study was to evaluate the role of abdominal and pelvic ultrasound in ERAS to assess the gastro-intestinal motility after colorectal surgery, and its effect on the postoperative hospital stay
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,colorectal cancer,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 06/02/2018
Actual Last follow-up date 06/02/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
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 closed envelop technique Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound ERAS ultrasound done 24 hours after surgery and repeated every 12 hours until the intestinal motility is found every 12 hours till the intestinal motility is detected abdominal and pelvic ultrasound 24 hours after surgery using abdominal probe 3.5 M.H.Z. at least for 10 minutes to assess gastrointestinal motility. Once the intestinal motility recognized the patient allowed to initiate the oral fluid if tolerated it and then allowed to start soft diet. If there is no intestinal motility the abdomino-pelvic ultrasound will repeated every12 hours until presence 30 Uncontrolled
Control Group ERAS NA till discharge no ultrasound is done start oral immediately after surgery 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with colorectal cancer in cairo university hospital (kasr alaina) previous history of major abdominal surgery patients with electrolyte imbalance as hypokalemia peritonitis emergency operations. 18 Year(s) 100 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 06/02/2017 surgery department ethical committie
Ethics Committee Address
Street address City Postal code Country
elsaray st Giza 11232 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Period of Hospital stay patient discharged readmission
Secondary Outcome nausea, vomiting, start of oral intake, passage of flatus or stools from day 1 till discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university hospital (Kasr Alainy) elsaraya st. elmanial Giza 11232 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
surgery department cairo university elsaray st Giza 11232 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hany Mikhail 9 galal hagag Cairo 15543 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Farag elsaray st Giza 11132 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Mikhail hanymikhail@kasralainy.edu.eg 00201223980297 9 elshaheed galal haga
City Postal code Country Position/Affiliation
cairo 11234 Egypt Associate professor of surgery, Cairo University
Role Name Email Phone Street address
Public Enquiries Hany Mikhail hanymikhail@kasralainy.edu.eg 00201223980297 9 elshaheed galal hagag
City Postal code Country Position/Affiliation
Cairo 11234 Egypt Associate professor of surgery, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hany Mikhail hanymikhail@kasralainy.edu.eg 00201223980297 9 elshaheed galal hagag
City Postal code Country Position/Affiliation
cairo 11234 Egypt Associate professor of surgery, Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information