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.: PACTR201907742754947 Date of Approval: 12/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Complete mesocolic excision vs. standard laparoscopic right hemicolectomy
Official scientific title Complete mesocolic excision versus standard laparoscopic right hemicolectomy in Egyptian
Brief summary describing the background and objectives of the trial Complete mesocolic excision and central vascular ligation results in a larger specimen with more lymph nodes than standard of care right hemicolectomy by laparoscopic surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,colon cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 31/12/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
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 by computer software sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Complete Mesocolic Excision Complete mesocolic excision and central vascular ligation results 40 Active-Treatment of Control Group
Control Group standard of care right hemicolectomy standard of care right hemicolectomy for right colon cancer 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 18+ years 2. Provision of written informed consent 3. Biopsy proven colonic adenocarcinoma located proximal to the mid transverse colon 4. Acceptable clear distal margin possible without division of the middle colic vessels 5. Local Multi Disciplinary Team recommends right hemicolectomy 6. Treatment undertaken with curative intent 7. Elective/scheduled operation 8. Patients fit for surgery 9. Minimal staging investigations performed - CT chest/abdomen/pelvis and full colonic assessment 1. Patient refusal 2. Any neoadjuvant treatment (including stenting) 3. Treatment undertaken with palliative intent 4. Emergency surgery (unplanned resection within 48hrs of admission) 5. More extensive colonic resection surgery required or performed (extended right hemicolectomy - division of all middle colic vessels, subtotal colectomy) 6. R1/R2 on histopathological assessment Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 23/12/2017 alexandria ethical comitee
Ethics Committee Address
Street address City Postal code Country
San stefano alexandria 00000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Size of resection specimen done immediate after resection
Primary Outcome Number of lymph nodes present done after one week by the pathologist
Secondary Outcome Operative time (minutes) intraoperative
Secondary Outcome Blood loss (ml) intraoperative by swab weight and suction volume
Secondary Outcome Length of hospital stay postoperative days
Secondary Outcome Early morbidity 30 day postoperative complications, Clavien-Dindo Classification, prospective observational recording from case notes and clinical team
Secondary Outcome Surgical technique (laparoscopic, size of specimen, number of lymph nodes)
Secondary Outcome Extent of standard of care right hemicolectomy surgery specimen size number of lymph nodes post-operative histopathological assessment)
Secondary Outcome Early morbidity 30 day postoperative complications Clavien-Dindo Classification, prospective observational recording from case notes and clinical team
Secondary Outcome Surgical technique laparoscopic size of specimen number of lymph nodes
Secondary Outcome Extent of standard of care right hemicolectomy surgery specimen size number of lymph nodes post-operative histopathological assessment
Secondary Outcome Three year disease free and overall survival observational recording from Multi Disciplinary Team records
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria main university hospital el azzaritta Alexandria 20122 Egypt
Loran hospital sharawy st alexandria 21115 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
main university hospital alexandria el azzaritta Alexandria 21212 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria main university hospital el azzaritta Alexandria 21212 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Walid galal Elshazly 1 ahmed zaki abo shadi alexandria 21111 Egypt
Mohamed abd elhalim 21 el ekbal st loran Alexandria 22211 Egypt
amr samir 15 sharawy st Alexandria 22315 Egypt
Ahmed Radwan 12 cleopatre Alexandria 21215 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Galal Elshazly wshazly@gmail.com 01223493268 1 st ahmed zaki abo shadi
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt professor of colorectal surgery
Role Name Email Phone Street address
Public Enquiries Israa aly israa.aly@alexmed.edu.eg 0021287740750 el mery El azzaritaa
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt ethical committe
Role Name Email Phone Street address
Scientific Enquiries mohmed halim immerlanz@hotmail.com 002110711171 el mery El azzaritaa, colorectal unit
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt scientific activity organizer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Proposal should be directed to wshazly@gmail.com To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link will be provid 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