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.: PACTR201602001417239 Date of Approval: 10/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Polypropylene-based composite mesh versus standard polypropylene mesh in the reconstruction of complicated large abdominal wall hernias
Official scientific title Polypropylene-based composite mesh versus standard polypropylene mesh in the reconstruction of complicated large abdominal wall hernias: A prospective randomized study
Brief summary describing the background and objectives of the trial Large defects of the abdominal wall caused by incisional hernia and abdominal masses still represent a challenging problem in plastic, reconstructive, and abdominal surgery. For their successful tension-free repair a proper selection of reconstructive material is essential. In the last decades, the use of synthetic meshes was dominant while biological autodermal grafts were rarely used. Abdominal wall defects result from trauma, abdominal wall tumors, necrotizing infections or complications of previous abdominal surgeries. Apart from cosmetics, abdominal wall defects have strong negative functional impact on the patients. Many different techniques exist for abdominal wall repair. Most problematic and troublesome are defects, where major part of abdominal wall had to be resected and tissue for transfer or reconstruction is absent.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 31/10/2015
Actual trial start date 10/01/2016
Anticipated date of last follow up 10/02/2016
Actual Last follow-up date 10/02/2016
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using closed envelope technique sealed opaque envelopes technique Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Mesh repair Composite mesh 20 Active-Treatment of Control Group
Experimental Group mesh repair polypropylene mesh 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
large abdominal wall defects huge hernia desmoid tumors lumber hernias uncontrolled comorbidities unfit for anesthesia burst abdomen extremes of age > 20 year, > 65years 20 Year(s) 65 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 01/10/2015 faculty of medicine, alexandria university, egypt
Ethics Committee Address
Street address City Postal code Country
shamblion st, elazarita, alexandria, egypt alexandria 21532 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome complications infection of the mesh wound infection chest infection
Secondary Outcome late complications hernia recurrence after mesh repair
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine, alexandria university, egypt shamblion st, elazarita, alexandria alexandria 21532 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine, alexandria university, egypt shamblion st, elazarita, alexandria alexandria 21532 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Ibrahim kassem, faculty of medicine, alexandria university shamblion st, elazarita, alexandria alexandria 21532 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ibrahim kassem, faculty of medicine, alexandria university shamblion st, elazarita, alexandria alexandria 21532 Egypt
Hany Mostafa Elhaddad shamblion st, elazarita, alexandria alexandria 21532 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed kassem dr_m_kassem@yahoo.com +201001224750 17 shaarawy st, louran, alexandria
City Postal code Country Position/Affiliation
alexandria 21615 Egypt assistant professor of surgery , faculty of medicine, alexandria university, egypt
Role Name Email Phone Street address
Public Enquiries Hani Elhaddad drhanyelhaddad@yahoo.com +201001989132 mosheer ah. ismaeil st. sidi gaber, alexandria
City Postal code Country Position/Affiliation
alexandria Egypt lecturer of surgery, faculty of medicine, alexandria university, egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Kassem dr_m_kassem@yahoo.com +201001224750 shamblion st. GIT surgery departement, faculty of medicine, alexandria university, egypt
City Postal code Country Position/Affiliation
alexandria Egypt assistant professor of surgery, faculty of medicine, alexandria university, egypt
REPORTING
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