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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202511671623081 Date of Registration: 17/11/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Plication of Fascia Transversalis to Reduce Seroma Formation Post Laparoscopic Transabdominal Preperitoneal Repair for Direct Inguinal Hernia
Official scientific title Plication of Fascia Transversalis in Comparison to no Plication to Reduce Seroma Formation Post Laparoscopic Transabdominal Preperitoneal Repair for Direct Inguinal Hernia : a Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Laparoscopic transabdominal preperitoneal (TAPP) mesh repair has enhanced postoperative outcomes in inguinal hernia surgery; however, seroma formation continues to be a frequent complication, especially in direct hernias. Various preventive techniques have been proposed to mitigate this issue,yet no approach has been standardized. This study aimed to evaluate the effectiveness of transversalis fascia plication in reducing the occurrence of postoperative seroma.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/07/2024
Actual trial start date 31/07/2024
Anticipated date of last follow up 30/10/2025
Actual Last follow-up date 31/10/2025
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 146
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
MS.142.2024 Ethics committee research . faculty of medicine. cairo university
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Plication of Fascia Transversalis 30 days Plication of Fascia Transversalis durring TAPP for laparascopic direct hernia repair 73
Control Group no Plication of Fascia Transversalis durring TAPP for laparascopic direct hernia repair 30 days no Plication of Fascia Transversalis durring TAPP for laparascopic direct hernia repair 73 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study included adult patients (>18 years) diagnosed clinically with direct inguinal hernia who were scheduled for TAPP mesh hernioplasty. • Patients with indirect or pantaloon inguinal hernia (discovered intraoperatively) • Patients with recurrent hernia • Conversion to open surgery • Undergoing concurrent surgical procedures 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 100 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 24/07/2024 research ethics committee faculty of medicine cairo university
Ethics Committee Address
Street address City Postal code Country
elmanial cairo 7268 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of postoperative seroma..The presence of seroma was diagnosed clinically (by detection of a groin swelling ormass that has no impulse on cough) and confirmed by ultrasonography (Sac containing collection with no vascularity). 30 days POSTOPERATIVE
Secondary Outcome Pain (VAS score at 1, 10 and 30 days), incidence of complications (e.g., bleeding, infection, urinary retention), hernia recurrence within 30 days. 30 days POSTOPERATIVE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kasralainy faculty of medicine elmanial cairo 7268 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university elmanial cairo 7268 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohammed elshwadfy nageeb elmanial cairo 7268 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed elshwadfy mohammedelshwadfy@kasralainy.edu.eg 002025524630 elmanial
City Postal code Country Position/Affiliation
cairo Egypt cairo university
Role Name Email Phone Street address
Public Enquiries ali asaal aliasal.7.96@gmail.com 00201032036583 elmanial
City Postal code Country Position/Affiliation
cairo Egypt cairo university
Role Name Email Phone Street address
Scientific Enquiries khaled torfa khaled.mosleh@scholar.edu.eg 00201225232551 elmanial
City Postal code Country Position/Affiliation
cairo Egypt cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The de-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding author after publication. The data will include baseline characteristics, outcome measures, and adverse events. Access will be granted to researchers who provide a methodologically sound proposal and sign a data access agreement. Study Protocol 6 months available wthin kasralainy data system on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/11/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 08/11/2025 Result - 03/11/2025 Result - 03/11/2025 Result - 03/11/2025 Result - 03/11/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/11/2025 POSTOPERATIVE Primary Outcome, the incidence of postoperative seroma..The presence of seroma was diagnosed clinically (by detection of a groin swelling ormass that has no impulse on cough) and confirmed by ultrasonography (Sac containing collection with no vascularity)., 30 days Primary Outcome, the incidence of postoperative seroma..The presence of seroma was diagnosed clinically (by detection of a groin swelling ormass that has no impulse on cough) and confirmed by ultrasonography (Sac containing collection with no vascularity)., 30 days POSTOPERATIVE
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/11/2025 INDICATE POSTOPERATIVE DAYS Secondary Outcome, Pain (VAS score at 1, 10 and 30 days), incidence of complications (e.g., bleeding, infection, urinary retention), hernia recurrence within 30 days., 30 days Secondary Outcome, Pain (VAS score at 1, 10 and 30 days), incidence of complications (e.g., bleeding, infection, urinary retention), hernia recurrence within 30 days., 30 days POSTOPERATIVE
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 08/11/2025 response to reviewer Patient ID Group Age gender BMI Comorbidities Hernia side Hernia type Defect Size (cm) Plication Type of Mesh (Lightweight/Heavyweight) Mesh Fixation Duration of Surgery (min) Hospital Stay (days) Seroma at Post-op Day 2 Seroma at Day 10 Seroma at Day 30 Pain Score at Post-op Day 2 Pain Score at Day 10 Follow-up Pain Score at Day 30 Follow-up Chronic Pain at Month 3 (Yes/No) Hernia Recurrence at 30 Days (Yes/No) Post-op Complications Notes Preoperative Albumin (g/dL) Smoking Status (Yes/No) Diabetes Mellitus (Yes/No) Hypertension (Yes/No) Anticoagulant Use (Yes/No) Bilateral Hernia (Yes/No) Previous Groin Surgery (Yes/No) Hernia Size Type The de-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding author after publication. The data will include baseline characteristics, outcome measures, and adverse events. Access will be granted to researchers who provide a methodologically sound proposal and sign a data access agreement.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 08/11/2025 correct as inclusion criteria more than 18 years 18 Year(s) 19 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 08/11/2025 uploaded a summary result overview containing Baseline characteristics, Participant flow (CONSORT flow diagram), Adverse events (if applicable) and Outcome measures 38463_26773_1045.pdf 38463_26773_1045.pdf