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.: PACTR201809865973520 Date of Approval: 17/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The role of Diagnostic Laparoscopy in Abdominal Masses
Official scientific title The role of Diagnostic Laparoscopy in Abdominal masses
Brief summary describing the background and objectives of the trial Assessment of the impact of diagnostic laparoscopy before the planned resection of an abdominal mass
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2010
Actual trial start date 01/08/2010
Anticipated date of last follow up 05/08/2011
Actual Last follow-up date 05/08/2011
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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 Diagnostic Laparoscopy 12 minutes 15 seconds Diagnostic laparoscopy 40
Control Group None 0 minutes None 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients diagnosed with an abdominal mass Patients unfit for surgery Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 31 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 23/06/2010 Alexandria medical school ethics comittee
Ethics Committee Address
Street address City Postal code Country
17 champilion street Alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect of Diagnostic laparoscopy on the management of the patient Immediately postopertatively
Secondary Outcome Complications of Diagnostic Laparoscopy 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospital Champilion street- Azarita Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University Hospital Azarita Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hisham El Zanati hishamzanati@yahoo.com 00447827260570 62 Jean Armour Drive
City Postal code Country Position/Affiliation
Kilmarnick United Kingdom Specialty Doctor in Surgery
Role Name Email Phone Street address
Public Enquiries Hisham El Zanati hishamzanati@yahoo.com 00447827260570 62 Jean Armour Drive
City Postal code Country Position/Affiliation
Kilmarnock United Kingdom Specialty Doctor in Surgery
Role Name Email Phone Street address
Scientific Enquiries Hisham El Zanati hishamzanati@yahoo.com 00447827260570 62Jean Armour Drive
City Postal code Country Position/Affiliation
Kilmarnock United Kingdom Specialty Doctor in Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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