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.: PACTR202508874855720 Date of Registration: 11/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of the effect of prosthetic mesh on spermatogenesis in laparoscopic transabdominal preperitoneal versus lichtenstien inguinal hernia repair
Official scientific title Comparative study of the effect of prosthetic mesh on spermatogenesis in laparoscopic transabdominal preperitoneal versus lichtenstien inguinal hernia repair.
Brief summary describing the background and objectives of the trial Background: Groin hernia is a common condition, with mesh repair now used in most cases due to its lower recurrence rate. The Lichtenstein technique remains the standard approach for its simplicity and effectiveness. Aim: To compare the impact of laparoscopic transabdominal preperitoneal (TAPP) versus open (Lichtenstein) inguinal hernia repair on ipsilateral testicular volume and spermatogenesis.
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: Surgery
Anticipated trial start date 01/03/2024
Actual trial start date 01/03/2024
Anticipated date of last follow up 01/02/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group open Lichtenstein repair 1 hour A 5–7 cm incision was made medial to the line among the pubic tubercle and anterior superior iliac spine. Layers were dissected to expose the external oblique aponeurosis, which has been opened parallel to its fibers, preserving the nerves. Dissection continued through the internal oblique and transversus abdominis to reach and open the transversalis fascia. In indirect hernias, the sac was separated from the cord or transected and closed proximally if not easily dissected. A preperitoneal pocket was created for mesh placement, extending medially to the pubic symphysis and laterally beyond the deep inguinal ring. The mesh was placed with three-fifths over and two-fifths under the inguinal ligament. In spinal cases, the patient was asked to cough to check mesh positioning. Closure was performed using 2/0 prolene for the aponeurosis, absorbable sutures for subcutaneous tissue, and non-absorbable sutures for skin. No drains were used 40 Active-Treatment of Control Group
Experimental Group laparoscopic transabdominal preperitoneal group 1 hour Patients were placed in a 10–20° Trendelenburg position. A urinary catheter was inserted post-anesthesia, and a Ryle’s tube was used if needed. Pneumoperitoneum was established via a supraumbilical Veress needle (pressure up to 15 mmHg), followed by insertion of a ten-millimeter camera port and two five-millimeter working ports. The hernia sac and surrounding structures (spermatic vessels, inferior epigastric vessels, etc.) were identified. A peritoneal flap was raised, and the hernia sac was reduced or resected as appropriate. Dissection extended medially to the symphysis pubis. A 15×12 centimeter polypropylene mesh has been inserted and fixed to Cooper’s ligament and the anterior abdominal wall using tacks, covering the myopectineal orifice. The peritoneum was reapproximated with sutures, CO₂ was evacuated, and port sites were closed. Blood loss was measured via suction canister. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
male with primary or bilateral inguinal hernia femoral or irreducible hernias Previous inguinal hernia surgery sexual dysfunction significant cardiac or vascular pathology that may affect testicular blood flow Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Male
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 13/02/2024 the research ethical committee at faculty of medicine Al Azhar university
Ethics Committee Address
Street address City Postal code Country
king faisal St Assuit 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome changes in semen Analysis 3 months after the operation
Secondary Outcome complication of surgery 3 months after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar university hospital king faisal st Assuit Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar university king faisal st Assuit Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university king faisal st Assuit Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Salem mohamed00salem10@gmail.com 00201094613873 Damas st
City Postal code Country Position/Affiliation
Mit Ghamr Egypt Resident of Surgery Al Azhar university hospital in Assuit
Role Name Email Phone Street address
Public Enquiries Saad Ali saadmohaly1985@gmail.com 002201009950199 Saft Zariq
City Postal code Country Position/Affiliation
Deirb Negm Egypt Lecturer of Surgery Al Azhar university hospital
Role Name Email Phone Street address
Scientific Enquiries Abdelmoneim Adam monemadam2016@gmail.com 00201111106805 12 Ali Ibn Abi Talib Street
City Postal code Country Position/Affiliation
Sohag Egypt Assistant Professor of surgery Al Azhar University hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification(text, tables ,figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication. open
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/08/2025 PACTR Admin 01 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 11/08/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)