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.: PACTR202306866557562 Date of Approval: 27/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and Feasibility of Enhanced Recovery after Open Renal Surgery in Cairo University Hospital
Official scientific title Efficacy and Feasibility of Enhanced Recovery after Open Renal Surgery in Cairo University Hospital
Brief summary describing the background and objectives of the trial Advances in medical technology has allowed for the existence of minimally invasive surgical techniques which has been useful for different surgeries especially renal surgeries. However, a more traditional open approach is many times needed due to the patient’s condition or the nature of the disease or its recurrence. These surgeries entail many factors that may limit early discharge, for example, pain from the lumbar incision, atelectasis, ileus, and nausea, which results in longer length of hospital stay. Enhanced recovery after surgery (ERAS) is a multidisciplinary concept that can improve recovery, optimize physiological condition, and reduce surgical stress and complications; yet there is lack of research concerning ERAS after open renal surgery. ERAS includes different perioperative strategies that are mostly investigated on an individual basis as avoiding prolonged fasting, reducing opioid usage, early initiation of oral diet, and early mobilization. Our aim was to implement these different methods into a single multimodal perioperative care protocol with the hypothesis that this combination will be of greater benefit than conventional perioperative management for the patients, regarding the reduction of length of hospital stay, incidence of complications and readmission rate in patients undergoing open renal surgery.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2022
Actual trial start date 01/09/2022
Anticipated date of last follow up 31/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 65
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Enhanced Recovery After Surgery Starting preoperatively (1 day before surgery) and continued intraoperatively and postoperatively till the patient’s discharge (up to 7 days after surgery). Adult patients scheduled for open renal surgery under general anesthesia, ASA grade I-II were included in this study. They have been educated about the nature of the procedure and its possible complications as well as the ERAS plan to encourage their cooperation. Preoperatively, they were encouraged regarding smoking reduction (if any), limiting the period of fasting, and taking of sugar drinks. Intraoperatively, prophylactic antibiotics, anxiolytics, and proper premedication were given, which was supported by using regional anesthesia (erector spinae plane block), administering balanced fluid, preventing hypothermia, maintaining normoglycemia, and thromboembolic prophylaxis. Postoperatively, pain control with minimizing opioids and shift to oral alternatives, early oral intake and minimizing IV therapy, preventing constipation, early mobilization and exercise, early removal of nephrostomy tubes and urinary catheters, and early resumption of chronic preoperative therapy. 65
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients (age 18-60) Scheduled for open renal surgery under general anesthesia ASA grade I or II Patient refusal Extremes of age (below 18 years or above 60 years) ASA grade III or IV Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 29/08/2022 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Length of hospital stay Postoperatively up to 7 days
Secondary Outcome Incidence of complications and readmission rate Postoperatively up to 7 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasr Al Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Victor Farouk Jaccoub Kasr Al Ainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospital Kasr Al Ainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Victor Jaccoub victor.jaccoub44@gmail.com +201274488860 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Victor Jaccoub victor.jaccoub44@gmail.com +201274488860 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Principal Investigator Manar El Khouly manarelkholy@kasralainy.edu.eg +2000000000000 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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