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.: PACTR201602001479105 Date of Approval: 19/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title laparscopic versus open rectal resection
Official scientific title CRT laparscopic versus open surgery for rectal cancer
Brief summary describing the background and objectives of the trial Laparoscopic surgery has progressively replaced open colonic surgery in recent decades owing to favorable short-term outcomes, such as less pain, reduced blood loss, and improved recovery time. The current study was designed to compared laparoscopic versus open surgery in patients with rectal cancer by incorporating clinical endpoints and detailed pathological analysis of all resected samples
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,rectal cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2014
Actual trial start date 01/01/2014
Anticipated date of last follow up 01/01/2016
Actual Last follow-up date 01/01/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lap-arscopic rectal resection lap-arscopic rectal resection for cancer 40
Control Group open rectal resection for cancer rectum surgical procedure for cancer retum patient 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a solitary adenocarcinoma of the rectum within 15 cm from the anal verge without distant metastases who were candidates for elective surgery were eligible for inclusion Cardiovascular or pulmonary instability or failure Severe or unstable chronic obstructive pulmonary disease or cardiac disease Coagulopathy not correctable preoperatively Extreme obesity Pregnancy Tumor extensively involving contiguous structures Diffuse peritoneal contamination with perforated viscus Acute inflammatory bowel disease (fever, distension, other signs of toxicity) associated with the malignancy Eneroenteric or enterocutaneous fistula Multiple previous abdominal surgeries Obstruction of the intestine with abdominal distension 20 Year(s) 90 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 03/02/2014 Alexandria ethical committe
Ethics Committee Address
Street address City Postal code Country
el azzaritta alexadria 20122 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative clinical outcome in terms of morbidity and mortality postoperative clinical outcome in terms of morbidity and mortality at first 28 days post operative
Secondary Outcome adequacy of surgical margins and number of lymph nodes harvested for colorectal cancer cases. adequacy of surgical margins and number of lymph nodes harvested for colorectal cancer cases. after specimen retriveal
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria EL azzariita Alexandria 21111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexnandria university el azzaitta alexandria 20123 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria main university hospital elazzaritta alexandria 20122 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
walid galal elshazly zaky abo shady alexandria 20111 Egypt
khalid saed smoha alexandria 20124 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator walid elshazly wshazly@hotmail.com 034812434 el azzaitta
City Postal code Country Position/Affiliation
alexandria 21111 Egypt Ass. Prof
Role Name Email Phone Street address
Public Enquiries israa aly israa.aly@alexmed.edu.eg 0021287740750 elazzaritta
City Postal code Country Position/Affiliation
alexandria 20123 Egypt Prof
Role Name Email Phone Street address
Scientific Enquiries wahid elshazly wshazly@gmail.com 01223493268 elazzaitta
City Postal code Country Position/Affiliation
alexandria 20123 Egypt head of surgical department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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