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.: PACTR202607799152725 Date of Registration: 31/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Defect Closure on Outcomes in Laparoscopic Direct Inguinal Hernia Repair: A Prospective Comparative Study
Official scientific title Impact of Defect Closure on Outcomes in Laparoscopic Direct Inguinal Hernia Repair: A Prospective Comparative Study
Brief summary describing the background and objectives of the trial Seroma formation is one of the most common postoperative complications following laparoscopic repair of direct inguinal hernias, particularly in the presence of a large fascial defect and redundant transversalis fascia. Various techniques have been proposed to reduce postoperative seroma formation; however, each has its own limitations. Closure of the direct hernia defect has emerged as a potential strategy to obliterate the dead space and minimize seroma development. Therefore, this study aimed to compare defect closure versus non-closure during transabdominal preperitoneal (TAPP) repair of direct inguinal hernias regarding postoperative seroma formation, operative time, postoperative pain, surgical site complications, and early recurrence.
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 01/12/2023
Actual trial start date 01/12/2023
Anticipated date of last follow up 01/12/2025
Actual Last follow-up date 01/12/2025
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 116
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
Experimental Group Defect closure 2 years The apex of the attenuated transversalis fascia (direct hernia pseudosac) was grasped and inverted, and 2-0 Vicryl sutures was placed between the pseudosac and Cooper’s ligament or abdominal wall to obliterate the residual dead space. 56
Control Group Non defect closure 2years No closure or obliteration was don for the direct hernia pseudosac 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any case with direct inguinal hernia candidate for laparoscopic TAPP, 18- 70 years old, male or female, either unilateral or bilateral hernia. we excluded the cases with indirect inguinal hernia, direct inguinal hernia without defect, cases with concomitant procedure or other groin hernia, complicated hernia, recurrent hernia, cases who were converted to open approach, cases who were unfit for general anesthesia or pneumoperitoneum, and cases with coagulopathy. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 22/10/2023 Ain Shams University Faculty of Medicine Ethic Committe RECResearch General surgery department
Ethics Committee Address
Street address City Postal code Country
Ramsis street Cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was postoperative seroma formation. Seroma was defined as a localized fluid collection in the preperitoneal space detected by ultrasonography at the 1-month follow-up visit or as a clinically evident, non-tender hemispherical swelling at the surgical site without a cough impulse, subsequently confirmed by ultrasonography during the follow-up period. 6 months post intervention
Secondary Outcome Secondary outcomes included intraoperative variables (operative time, estimated blood loss, intraoperative complications, and conversion to open surgery) and postoperative outcomes (length of hospital stay, postoperative pain, hematoma, orchitis, urinary retention, surgical site infection, and early hernia recurrence). Postoperative pain was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), on postoperative day 1 and during follow-up visits at 1 week and 1 month. 6 months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospitals Ramsis street Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hossam Sobhy Abdelrahim Ramsis street Cairo 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors with no external sponsorship Ramsis street Cairo 002 Egypt Authors
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 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Assistant professor of general surgery department Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Tasnim Naeem Tasnim.naeem@gmail.com 00201007982183 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery department Ain shams university
Role Name Email Phone Street address
Public Enquiries Ahmed Saad ahmedsaeed@med.asu.edu.eg 00201001600271 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery department Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elshawy Drmohamedelemam@med.asu.edu.eg 00201001851755 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery department Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol and informed consents for the individual participant data are allowed for sharing under a data use agreement, with restrictions to protect participant privacy Informed Consent Form,Study Protocol 2 years after publication researchers upon request by direct contact
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
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 25/07/2026 To clarify the 6 months follow up when is it pre-,during or post-intervention Primary Outcome, The primary outcome was postoperative seroma formation. Seroma was defined as a localized fluid collection in the preperitoneal space detected by ultrasonography at the 1-month follow-up visit or as a clinically evident, non-tender hemispherical swelling at the surgical site without a cough impulse, subsequently confirmed by ultrasonography during the follow-up period., 6 months Primary Outcome, The primary outcome was postoperative seroma formation. Seroma was defined as a localized fluid collection in the preperitoneal space detected by ultrasonography at the 1-month follow-up visit or as a clinically evident, non-tender hemispherical swelling at the surgical site without a cough impulse, subsequently confirmed by ultrasonography during the follow-up period., 6 months post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 25/07/2026 To clarify the 6 months follow up when is it pre-,during or post-intervention Secondary Outcome, Secondary outcomes included intraoperative variables (operative time, estimated blood loss, intraoperative complications, and conversion to open surgery) and postoperative outcomes (length of hospital stay, postoperative pain, hematoma, orchitis, urinary retention, surgical site infection, and early hernia recurrence). Postoperative pain was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), on postoperative day 1 and during follow-up visits at 1 week and 1 month., 6 months Secondary Outcome, Secondary outcomes included intraoperative variables (operative time, estimated blood loss, intraoperative complications, and conversion to open surgery) and postoperative outcomes (length of hospital stay, postoperative pain, hematoma, orchitis, urinary retention, surgical site infection, and early hernia recurrence). Postoperative pain was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), on postoperative day 1 and during follow-up visits at 1 week and 1 month., 6 months post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 25/07/2026 It is an unintentional mistake to put the email address of ethical committee the same as PI one TRUE, Ain Shams University Faculty of Medicine Ethic Committe RECResearch General surgery department, Ramsis street, Cairo, 002, Egypt, , 22 Oct 2023, 00201110540267, hosam_l_n@yahoo.com, 43714_40041_4737.pdf TRUE, Ain Shams University Faculty of Medicine Ethic Committe RECResearch General surgery department, Ramsis street, Cairo, 002, Egypt, , 22 Oct 2023, 00201110540267, Ahismail2002@yahoo.com, 43714_40041_4737.pdf