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.: PACTR202109549974384 Date of Approval: 23/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Component separation techniques in large ventral hernia
Official scientific title Posterior Components Separation with Transversus Abdominis Release Versus Anterior Component Separation in Ventral Abdominal Hernia, a prospective comparative study
Brief summary describing the background and objectives of the trial Large ventral abdominal hernia is a complex problem to many surgeons. Different techniques of component separation have emerged to deal with this problem. The key step in component separation is the plane of lateral dissection which facilitates closure of the defect with tension free. It is a prospective comparative study to compare between anterior component separation and posterior component separation with tranversus abdominus muscle release in large ventral hernia
Type of trial CCT
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: Surgery
Anticipated trial start date 15/12/2019
Actual trial start date
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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 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
Control Group Group 1 ACS 2 years Anterior component separation: retrorectus dissection then subcutaneous dissection up to 3 cm lateral to linea semilunaris then longitudinal incision of external oblique aponeurosis to dissect between it and the underlying internal oblique muscle then closure of posterior fascial layer and sublay mesh applying then closure of anterior fascial layer. 40 Active-Treatment of Control Group
Experimental Group Group 2 PCSTAR 2 years retrorectus dissection until linea semilunaris, incision the posterior sheath to expose the underlying transversus abdominis muscle which is divided to pass in the retromuscular space until retroperitoneal space, closure of posterior layer then applying subly mesh then closure the anterior layer. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) All VAH with defect size ≥ 10cm (measured by CT scan). 2) Age from 18-65 years old. 3) Single defect. 1) Previous abdominoplasty. 2) Defect size < 10 cm. 3) VAH with loss of domain (identified clinically and by CT study) (15). 4) Recurrence after any type of C.S. 5) Previous stoma. 6) Previous abdominal flap reconstruction. 7) VAH includes multiple defects. 8) Complicated VAH (obstructed or strangulated). 9) Inflammatory bowel disease. 10) Bleeding tendency disease or patient on anticoagulation, antiplatelet medication. 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) 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 08/12/2019 Ethic committee of department of general surgery faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
Cairo Cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome recurrence rate 1 year postoperatively
Secondary Outcome operative time , blood loss, wound complication, failure intraoperative and postoperative for 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals Cairo Egypt Cairo 002 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 The authors of the study were the only sponsors with no external sponsoring Cairo Cairo 002 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam Abdelrahim Hosam_l_n@yahoo.com 00201110540267 Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery Ain shams university
Role Name Email Phone Street address
Public Enquiries Ehab Fadl dr.ehabfadl@med.asu.edu.eg 00201019660997 Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of surgery Ain shams University
Role Name Email Phone Street address
Scientific Enquiries Haitham Elmaleh dr_haitham_elmaleh@med.asu.edu.eg 00201006383143 Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt assistant professor of surgery Ain shams University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Amer drfo2sh@hotmail.com 00201006208888 Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of surgery Ain shams University
Role Name Email Phone Street address
Principal Investigator Mohammed Abo Elnaser Mm.hassanein25@gmail.com 00201281391455 Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Resident of general surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report. Informed Consent Form,Statistical Analysis Plan Immediately following publication, No end date All data will be open access for researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Hosam_l_n@yahoo.com 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