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.: PACTR201901464065582 Date of Approval: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Enhanced Recovery Protocol versus Conventional Protocol on Patients Outcome in Colorectal Surgeries
Official scientific title Effect of Enhanced Recovery Protocol versus Conventional Protocol on Patients Outcome in Colorectal Surgeries
Brief summary describing the background and objectives of the trial Colorectal cancer is one of the most frequent solid tumors in the Western world, and is the second most common cause of cancer death in the UK. its incidence was estimated in the American cancer society about 1 in 21men and 1 in 23 women. Enhanced recovery after surgery (ERAS) programs are evidence-based protocols designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress and organ dysfunction related to elective procedures. In addition, improved outcomes, decreased hospital length of stay and faster patient recovery to normal life are expected to be obtained. So Enhanced recovery is a combination of elements of care for elective surgery which aims to: Optimize pre-operative preparation for surgery; avoid iatrogenic problems such as postoperative ileus; minimize the stress response to surgery; speed recovery and return to normal function and recognize abnormal recovery and intervene if necessary. The aim of this study is to evaluate the effect of enhanced recovery protocol versus conventional protocol on patient’s outcome as regard postoperative insulin resistance, hospital stay and early oral intake in colorectal surgeries.  
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2015
Actual trial start date 01/04/2016
Anticipated date of last follow up 30/08/2018
Actual Last follow-up date 30/11/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Enhanced recovery protocol 1 week preoperative till 3 days postoperatively Carbohydrate loading ,no mechanical bowel preparation, assessment of intraoperative fluid responsiveness, early postoperative feeding 15
Control Group Conventional protocol 1 week before up to 10 days postoperatively Fasting 12hr,mechanical bowel preparation, use CVC to guide fluid management, postoperative feeding after 3 days 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiology Physical Status I, II or III. With colorectal cancer Patient refusal. Patients who requires synchronous second major procedure during the operation. Patients who were anticipated to require intensive care unit (ICU) or high dependency unit (HDU) admission after the operation. ASA status > III. Operation time more than 3 hours. Patients who had stoma formation as a part of their procedure.   Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 01/10/2015 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time of oral intake When patient started the first oral feeding
Primary Outcome Insulin resistance Preoperative, immediately postoperative,24 hr. postoperative
Secondary Outcome Hospital stay Till discharge or death in hospital
Secondary Outcome Death Till discharge or death in hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Anesthesia and Surgical Intensive Care Faculty of Medicine Alexandria University Al kartoom square Alazareta Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Wessam aLAMRAWY 165 Elhoryea Street Elhadara Alexandria 21524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia and Surgical Intensive Care Faculty of Medicine Alexandria University 17 Champollion Street, El Messalah Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Salwa Sharawy 17 Champollion Street El Messalah Alexandria 21521 Egypt
Magda Abo Ollo 165 Elhoryea Street Elhadara Alexandria 21524 Egypt
Magdy Mansour 165 Elhoryea Street Elhadara Alexandria 21524 Egypt
Mohamed Samir Kamel 165 Elhoryea Street Elhadara Alexandria 21524 Egypt
Wessam Alamrawy 165 Elhoryea Street Elhadara Alexandria 21524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salwa Sharawy salwashaarawy@yahoo.com 00201223425079 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Magda Abo ollo magdaaboollo@hotmail.com 002012222201214 165 Elhoryea Street Elhadara
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Professor of Anesthesia and Pain Management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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