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.: PACTR202001663032667 Date of Registration: 30/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Contribution of the introduction of an information brochure when obtaining informed consent in surgery.
Official scientific title Contribution of the introduction of an information brochure when obtaining informed consent in surgery.
Brief summary describing the background and objectives of the trial background Preoperative information is a legal and ethical obligation. Very little studies have evaluated the preoperative information method in surgery. Improving information is a way to increase patients' satisfaction. objecives to examine patients' satisfaction and their memorization of written information
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial patient information brochure, evaluation of satisfaction and memorization
Anticipated trial start date 02/05/2013
Actual trial start date 02/05/2013
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 31/12/2015
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 135
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group information brochure delivery not applicable the brochure was delivered one week before surgery patients received oral and written information. 70
Control Group no intevention oral information only not applicable one week before surgery oral information only was delivered to patients 70 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients programed for : elective cholecystectomy, thyroidectomy and inguinal hernia repair urgent surgery cancer desease complicated cases associated surgical pathology patient who can't read and have no relative to red for them ptients who can't give consent for juridic ( minor ) or intelectual consideration Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 03/10/2013 ethics comitee for bimedical research CERB
Ethics Committee Address
Street address City Postal code Country
Av Abderrahim Bouabid Rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome satisfaction of delivered information before surgery , three days after delivering information
Primary Outcome memorization of the delivered information before surgery, three days after delivering information
Secondary Outcome satisfaction of the relation with the department organisation and team before surgery , three days after delivering information
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ibn Sina Hospital Surgical Department A Avenue Abderrahim Bouabid, Rabat Rabat 10100 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
El Malki Hadj Omar Abderrahim Bouabid Rabat 10100 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EL MALKI Hadj Omar Ibn Sina Hospital Rabat 10100 Morocco Individual
COLLABORATORS
Name Street address City Postal code Country
Zaari Ibtissam Abderrahim Bouabid rabat 10100 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hadj Omar EL MALKI omar.elmalki@um5.ac.ma +212661215977 Ibn Sina Hospital, Avenue Abderrahim Bouabid, Rabat
City Postal code Country Position/Affiliation
Rabat 10100 Morocco Mohammed V University Rabat medical school
Role Name Email Phone Street address
Public Enquiries Redouane ABOUQAL r.abouqal@um5s.net.ma +212537772981 Ibn Sina Hospital, Avenue Abderrahim Bouabid, Rabat
City Postal code Country Position/Affiliation
Rabat 10100 Morocco Mohammed V University Rabat medical school
Role Name Email Phone Street address
Scientific Enquiries Redouane ABOUQAL r.abouqal@um5s.net.ma +212537772981 Ibn Sina Hospital, Avenue Abderrahim Bouabid, Rabat
City Postal code Country Position/Affiliation
Rabat 10100 Morocco Mohammed V University Rabat medical school
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD that underlie results in a publication Clinical Study Report,Statistical Analysis Plan,Study Protocol starting 6 months after publication requests should be directed to: omar.elmalki@um5.ac.ma
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