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.: PACTR201912667453983 Date of Approval: 06/12/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Short Term Outcomes of Laparoscopic Intersphincteric Resection for ultra Low Rectal Cancer (ISR)
Official scientific title Short Term Outcomes of Laparoscopic Intersphincteric Resection for Low Rectal Cancer (ISR)
Brief summary describing the background and objectives of the trial to asses value of laparoscopic surgery in management of ultra low rectal cancer compared to open surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Rectal cancer
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 01/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 106
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 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 Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for ultra Low Rectal Cancer surgical operation 53
Control Group open surgical Intersphincteric Resection With Total Mesorectal Excision for ultra Low Rectal Cancer surgical operation 53 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with low rectal carcinoma (The lowest margin of tumor located 3 cm from anal verge ; ¿ 2 cm from dentate lines; 1 cm from anorectal rings. Local spread restricted to the rectal wall or the internal anal sphincter. Adequate preoperative sphincter function and continence. Absence of distant metastasis. Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4. Metastatic rectal cancer. Those in Dukes stage D (T4 lesion). Undifferentiated tumours. Local infiltration of external anal sphincter or levator ani muscles. Tumor located more than 2 cm above the dentate line. Presence of fecal incontinence. Patients unwilling to take part in the study. 18 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 01/01/2018 alexandria ethical comitee
Ethics Committee Address
Street address City Postal code Country
el mery elazzarita alexandria 00000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hospital stay Outcome observers will assess the hospital stay days after both procedures Time Frame: 2 months
Secondary Outcome Duration of the intervention Time Frame: 1 day
Secondary Outcome Amount of blood loss and rate of blood transfusion Time Frame: 1 Day
Secondary Outcome The onset of intestinal motility. Time Frame: 2 weeks, the onset of the intestinal motility guided by (the onset of borborygmus and its sequence, time to give off flatus, time to intake liquid and solid food)
Secondary Outcome Pain score Time Frame: the first two weeks in the postoperative period Recording of the needed analgesia guided by pain score
Secondary Outcome Postoperative complications Time Frame: 30 Days complications will be reported through the first 30 days postoperative
Secondary Outcome 30 days follow up for readmission in the postoperative period Time Frame: 1 month readmission within 30 days after patient discharge
Secondary Outcome Clinical functional outcome of intersphincteric resection Time Frame: 1 year
Secondary Outcome Local recurrence within 2 years Time Frame: 2 years
Secondary Outcome Distant metastasis within 2 years Time Frame: 2 years
Secondary Outcome conversion rate for laparoscopic ISR Time Frame: 1 day
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
El assafra hospital malak hefney st Alexandria 23255 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria main university hospital 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
omar walid galal 14 tagor st, El azzarita, Alexandria Alexandria 2123 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Galal Elshazly wshazly@gmail.com 002123493268 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 director
Role Name Email Phone Street address
Scientific Enquiries mohmed halim immerlanz@hotmail.com 002110711171 21 el ekbal loran
City Postal code Country Position/Affiliation
Alexandria 22211 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