Inguinal HerniaRCTNCT07401082
Mesh Fixation Methods in Laparoscopic Hernia Repair: Glue vs. Sutures vs. Tacks
A study testing Cyanoacrylate Surgical Adhesive Fixation, Suture Mesh Fixation and Helical Titanium Tack Fixation in people with Inguinal Hernia, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a clinical trial that aims to compare three different methods for securing a surgical mesh during a specific type of groin (inguinal) hernia repair surgery. The surgery is performed using a minimally invasive, keyhole technique called TAPP. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Cyanoacrylate Surgical Adhesive Fixation, Suture Mesh Fixation and Helical Titanium Tack Fixation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Sep 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 21 to 60 years
- Diagnosis of primary (de novo) inguinal hernia
- Hernia type: unilateral or bilateral, direct or indirect
- Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) repair
- Able to provide informed consent
Who cannot join
- Age <21 or >60 years
- Recurrent inguinal hernia
- Complicated hernia (irreducible, incarcerated, obstructed, or strangulated)
- Contraindication to laparoscopic surgery or general anesthesia
- Significant comorbid conditions making surgery high-risk (ASA class ≥III)
- Chronic pain syndrome or regular use of strong analgesics
Show all 9Show fewer
- Allergy to mesh materials (polypropylene) or fixation components (cyanoacrylate, titanium)
- Participation in another clinical trial
- Inability to complete follow-up or comply with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain and Quality of Life With Different Modalities of Mesh Fixation in Laparoscopic Trans-Abdominal Pre-Peritoneal Repair of Inguinal Hernia. A Randomized Controlled Trial
This study is a clinical trial that aims to compare three different methods for securing a surgical mesh during a specific type of groin (inguinal) hernia repair surgery. The surgery is performed using a minimally invasive, keyhole technique called TAPP.
The main questions this study aims to answer are:
Read more
Which mesh fixation method-surgical glue, stitches (sutures), or small metal coils (tacks)-results in less pain for patients after surgery?
Which method leads to a better quality of life and less feeling of the mesh inside the body after recovery?
Is there a difference in how long the surgery takes with each method?
To answer these questions, researchers will compare the three methods to see which one works best for patient comfort and recovery.
Adults aged 21-60 years with a new inguinal hernia who are having laparoscopic TAPP surgery can participate.
Participants will be randomly assigned to one of three groups:
Group 1: Their mesh will be secured using surgical glue.
Group 2: Their mesh will be secured using stitches (sutures).
Group 3: Their mesh will be secured using small metal coils (tacks).
All other parts of the surgery and care after surgery will be the same.
Participants will:
Have the laparoscopic TAPP hernia repair surgery.
Report their pain levels after surgery using a simple scale.
Answer questions about their comfort and quality of life during follow-up visits at 1, 3, and 6 months after surgery.
Read the detailed description
This study is a prospective, single-center, randomized controlled trial designed to compare the postoperative outcomes associated with three distinct mesh fixation modalities in laparoscopic Trans-Abdominal Pre-Peritoneal (TAPP) inguinal hernia repair.
Scientific Rationale:
While mesh reinforcement has drastically reduced recurrence rates in hernia surgery, chronic postoperative pain and mesh-related discomfort remain significant concerns that impact patient quality of life. The method of securing the mesh is hypothesized to be a key factor influencing these outcomes. Mechanical fixation with tacks or sutures may cause tissue trauma or nerve irritation, whereas adhesive fixation provides an atraumatic alternative. Direct comparative data on these three common techniques(glue, sutures, and tacks) within the standardized TAPP procedure is limited.
Study Design:
A total of 75 eligible participants will be enrolled and equally randomized into one of three parallel intervention arms in a 1:1:1 ratio. The randomization sequence will be computer-generated. Due to the nature of the interventions, blinding of the surgeon is not feasible; however, outcome assessors and the statistician will be blinded to group assignment where possible.
Interventional Protocol:
All participants will undergo a standardized TAPP procedure under general anesthesia. After creation of the preperitoneal space and placement of a polypropylene mesh over the myopectineal orifice, fixation will be performed according to the assigned group:
Glue Fixation Group: Fixation using a cyanoacrylate-based surgical adhesive (e.g., Glubran-2®) applied with a specific applicator.
Suture Fixation Group: Fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh.
Tack Fixation Group: Fixation using helical titanium tacks (e.g., ProTack®), with careful avoidance of the "triangle of doom" and "triangle of pain" anatomical zones.
Follow-up and Assessments:
Participants will be followed for a period of six months postoperatively. Structured assessments will occur at designated intervals:
Pain Assessment: Measured using the Visual Analogue Scale (VAS) on postoperative day 1 and at 1, 3, and 6 months.
Quality of Life and Mesh Sensation: Assessed using the Carolinas Comfort Scale (CCS), a validated hernia-specific questionnaire, at 1, 3, and 6 months.
Clinical Outcomes: Operative time, length of hospital stay, time to return to normal work/activities, incidence of complications (seroma, hematoma, infection), and hernia recurrence will be systematically recorded.
Statistical Analysis:
Data will be analyzed on an intention-to-treat basis. Continuous variables will be compared using ANOVA or Kruskal-Wallis tests as appropriate, followed by post-hoc pairwise comparisons. Categorical variables will be analyzed using the Chi-square or Fisher's exact test. A p-value of <0.05 will be considered statistically significant.
Study Significance:
This trial aims to provide high-level evidence to guide surgical practice by identifying the mesh fixation technique associated with the most favorable balance of reduced postoperative pain, improved quality of life, and cost-effectiveness, without compromising the durability of the repair.
- Conditions
- Inguinal Hernia
- Being tested
- Cyanoacrylate Surgical Adhesive Fixation, Suture Mesh Fixation, Helical Titanium Tack Fixation, Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .
- Keywords
- Inguinal hernia, Laparoscopic Hernia Repair, TAPP, Transabdominal Preperitoneal Repair, Mesh Fixation, Surgical Glue, Cyanoacrylate, Sutures, Tacks, Carolinas Comfort Scale, Postoperative Pain
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate Surgical Adhesive FixationDevice
Fixation of the polypropylene mesh using a cyanoacrylate-based surgical adhesive (Glubran-2®). The adhesive is applied in small drops at the mesh corners using a specific applicator device (GlueTack) to secure the mesh to the abdominal wall without mechanical penetration.
Suture Mesh FixationProcedure or surgery
Fixation of the polypropylene mesh using two non-absorbable polypropylene sutures. The sutures are placed laparoscopically at the medial and lateral ends of the mesh to mechanically secure it to the abdominal wall tissues (e.g., Cooper's ligament, transversalis fascia).
Helical Titanium Tack FixationDevice
Fixation of the polypropylene mesh using multiple helical titanium tacks ( ProTack®). The tacks are fired laparoscopically around the periphery of the mesh, penetrating the abdominal wall to mechanically secure the mesh in place, while avoiding anatomical danger zones.
Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .Procedure or surgery
All participants in this study will undergo Laparoscopic Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia, which is the standard surgical procedure. This minimally invasive technique involves:
Creation of Pneumoperitoneum: The abdominal cavity is inflated with carbon dioxide gas.
Port Placement: Three small incisions are made for camera and instrument ports.
Peritoneal Incision: The peritoneum (inner abdominal lining) is cut to access the preperitoneal space in the groin.
Hernia Reduction: The hernia sac and contents are pushed back into the abdominal cavity.
Mesh Placement: A synthetic polypropylene mesh is positioned to cover the entire myopectineal orifice (the weak area where hernias occur).
Mesh Fixation: The mesh is secured using one of three study methods (glue, sutures, or tacks) according to the assigned intervention arm.
Peritoneal Closure: The initial peritoneal incision is closed over the mesh to isolate it from the abdominal organs.
| Study group | Role | What they receive |
|---|---|---|
| Glue Mesh Fixation | Experimental | Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using a cyanoacrylate-based surgical adhesive (Glubran-2®) applied via a dedicated applicator (GlueTack device). The mesh will be secured with small drops of glue at its corners. Receives: Device: Cyanoacrylate Surgical Adhesive Fixation; Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . |
| Suture Mesh Fixation | Experimental | Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh. This is a traditional mechanical fixation method. Receives: Procedure: Suture Mesh Fixation; Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . |
| Tack Mesh Fixation | Active comparator | Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using helical titanium tacks (e.g., ProTack®). This is a standard mechanical fixation method commonly used in laparoscopic hernia repair. Tacks are placed around the periphery of the mesh, avoiding critical neurovascular zones. Receives: Device: Helical Titanium Tack Fixation; Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Intensity of pain measured using the Visual Analogue Scale (VAS), a 10-point scale where 0 = no pain and 10 = worst pain imaginable.
Measured: Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively.
Postoperative Quality of Life and Mesh Sensation
Patient-reported quality of life and mesh-related symptoms were measured using the Carolinas Comfort Scale (CCS), a validated hernia-specific outcome measure. The CCS consists of 23 items evaluating pain, mesh sensation, and movement limitation during daily activities, each scored from 0 (no symptoms) to 5 (disabling symptoms), yielding a total score range of 0-115. Higher scores indicate worse postoperative comfort and quality of life.
Measured: Assessed at 1 month, 3 months, and 6 months postoperatively.
Operative Time
Total duration of surgery, measured from skin incision to skin closure (in minutes).
Measured: Recorded on the day of surgery.
Secondary outcomes (5)
Hernia Recurrence
Clinical or radiological evidence of recurrent inguinal hernia at the operated site.
Measured: Assessed at 6 months postoperatively.
Time to Return to Work/Normal Activity
Number of days from surgery until the patient returns to their regular employment or daily activities.
Measured: Assessed within the first 4 weeks postoperatively.
Length of Hospital Stay
Number of days from surgery to discharge from the hospital.
Measured: Measured during the immediate postoperative period (typically 1-2 days).
Postoperative Complications
Incidence of surgical complications including seroma, hematoma, wound infection, mesh infection, and scrotal edema.
Measured: Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively
Direct Material Cost of Mesh Fixation Device
The direct material cost of the specific fixation device used in each study arm is recorded in US Dollars (USD). Costs are categorized into three predetermined ranges based on hospital procurement prices: Low ($30-60), Moderate ($200-300), and High ($350-500). Data will be aggregated and reported as the proportion of participants in each study arm falling into these cost categories.
Measured: Recorded on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start26 Sep 2024
- Primary completion5 Mar 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into one of three parallel groups (glue, sutures, tacks) and remain in that group for the duration of the study. All groups undergo the same surgical procedure (TAPP) with only the mesh fixation method differing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Eid Ali Ahmed Aziz, Cairo University
- Investigators
- Ahmed Eid Aziz, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401082
- Sponsor's protocol ID
- MS-358-2024
- Acronym
- RCT
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aziz AE, Khalil AH, Abdelnasser A, Elmonim AMA. Early postoperative pain and quality of life with different modalities of mesh fixation in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia: a randomized controlled trial. BMC Surg. 2026 Jun 9;26(1):377. doi: 10.1186/s12893-026-03801-7.
PubMed 42265662
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Quality of Life With Different Modalities of Mesh Fixation in Laparoscopic Trans-Abdominal Pre-Peritoneal Repair of Inguinal Hernia. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07401082
- Acronym / sponsor ID
- RCT / MS-358-2024
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, Laparoscopic Hernia Repair, TAPP, Transabdominal Preperitoneal Repair, Mesh Fixation, Surgical Glue, Cyanoacrylate, Sutures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a clinical trial that aims to compare three different methods for securing a surgical mesh during a specific type of groin (inguinal) hernia repair surgery. The surgery is performed using a minimally invasive, keyhole technique called TAPP.
The main questions this study aims to answer are:
Which mesh fixation method-surgical glue, stitches (sutures), or small metal coils (tacks)-results in less pain for patients after surgery?
Which method leads to a better quality of life and less feeling of the mesh inside the body after recovery?
Is there a difference in how long the surgery takes with each method?
To answer these questions, researchers will compare the three methods to see which one works best for patient comfort and recovery.
Adults aged 21-60 years with a new inguinal hernia who are having laparoscopic TAPP surgery can participate.
Participants will be randomly assigned to one of three groups:
Group 1: Their mesh will be secured using surgical glue.
Group 2: Their mesh will be secured using stitches (sutures).
Group 3: Their mesh will be secured using small metal coils (tacks).
All other parts of the surgery and care after surgery will be the same.
Participants will:
Have the laparoscopic TAPP hernia repair surgery.
Report their pain levels after surgery using a simple scale.
Answer questions about their comfort and quality of life during follow-up visits at 1, 3, and 6 months after surgery.
Detailed description
This study is a prospective, single-center, randomized controlled trial designed to compare the postoperative outcomes associated with three distinct mesh fixation modalities in laparoscopic Trans-Abdominal Pre-Peritoneal (TAPP) inguinal hernia repair.
Scientific Rationale:
While mesh reinforcement has drastically reduced recurrence rates in hernia surgery, chronic postoperative pain and mesh-related discomfort remain significant concerns that impact patient quality of life. The method of securing the mesh is hypothesized to be a key factor influencing these outcomes. Mechanical fixation with tacks or sutures may cause tissue trauma or nerve irritation, whereas adhesive fixation provides an atraumatic alternative. Direct comparative data on these three common techniques(glue, sutures, and tacks) within the standardized TAPP procedure is limited.
Study Design:
A total of 75 eligible participants will be enrolled and equally randomized into one of three parallel intervention arms in a 1:1:1 ratio. The randomization sequence will be computer-generated. Due to the nature of the interventions, blinding of the surgeon is not feasible; however, outcome assessors and the statistician will be blinded to group assignment where possible.
Interventional Protocol:
All participants will undergo a standardized TAPP procedure under general anesthesia. After creation of the preperitoneal space and placement of a polypropylene mesh over the myopectineal orifice, fixation will be performed according to the assigned group:
Glue Fixation Group: Fixation using a cyanoacrylate-based surgical adhesive (e.g., Glubran-2®) applied with a specific applicator.
Suture Fixation Group: Fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh.
Tack Fixation Group: Fixation using helical titanium tacks (e.g., ProTack®), with careful avoidance of the "triangle of doom" and "triangle of pain" anatomical zones.
Follow-up and Assessments:
Participants will be followed for a period of six months postoperatively. Structured assessments will occur at designated intervals:
Pain Assessment: Measured using the Visual Analogue Scale (VAS) on postoperative day 1 and at 1, 3, and 6 months.
Quality of Life and Mesh Sensation: Assessed using the Carolinas Comfort Scale (CCS), a validated hernia-specific questionnaire, at 1, 3, and 6 months.
Clinical Outcomes: Operative time, length of hospital stay, time to return to normal work/activities, incidence of complications (seroma, hematoma, infection), and hernia recurrence will be systematically recorded.
Statistical Analysis:
Data will be analyzed on an intention-to-treat basis. Continuous variables will be compared using ANOVA or Kruskal-Wallis tests as appropriate, followed by post-hoc pairwise comparisons. Categorical variables will be analyzed using the Chi-square or Fisher's exact test. A p-value of <0.05 will be considered statistically significant.
Study Significance:
This trial aims to provide high-level evidence to guide surgical practice by identifying the mesh fixation technique associated with the most favorable balance of reduced postoperative pain, improved quality of life, and cost-effectiveness, without compromising the durability of the repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomized into one of three parallel groups (glue, sutures, tacks) and remain in that group for the duration of the study. All groups undergo the same surgical procedure (TAPP) with only the mesh fixation method differing.
| Arm | Type | Receives |
|---|---|---|
| Glue Mesh Fixation | Experimental | Device: Cyanoacrylate Surgical Adhesive Fixation, Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using a cyanoacrylate-based surgical adhesive (Glubran-2®) applied via a dedicated applicator (GlueTack device). The mesh will be secured with small drops of glue at its corners. |
| Suture Mesh Fixation | Experimental | Procedure: Suture Mesh Fixation, Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh. This is a traditional mechanical fixation method. |
| Tack Mesh Fixation | Active comparator | Device: Helical Titanium Tack Fixation, Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using helical titanium tacks (e.g., ProTack®). This is a standard mechanical fixation method commonly used in laparoscopic hernia repair. Tacks are placed around the periphery of the mesh, avoiding critical neurovascular zones. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 21 to 60 years
- Diagnosis of primary (de novo) inguinal hernia
- Hernia type: unilateral or bilateral, direct or indirect
- Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) repair
- Able to provide informed consent
Key exclusion criteria (9 listed)
- Age <21 or >60 years
- Recurrent inguinal hernia
- Complicated hernia (irreducible, incarcerated, obstructed, or strangulated)
- Contraindication to laparoscopic surgery or general anesthesia
- Significant comorbid conditions making surgery high-risk (ASA class ≥III)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyanoacrylate Surgical Adhesive FixationFixation of the polypropylene mesh using a cyanoacrylate-based surgical adhesive (Glubran-2®). The adhesive is applied in small drops at the mesh corners using a specific applicator device (GlueTack) to secure the mesh to the abdominal wall without mechanical penetration. | Device | Glue Mesh Fixation |
| Suture Mesh FixationFixation of the polypropylene mesh using two non-absorbable polypropylene sutures. The sutures are placed laparoscopically at the medial and lateral ends of the mesh to mechanically secure it to the abdominal wall tissues (e.g., Cooper's ligament, transversalis fascia). | Procedure or surgery | Suture Mesh Fixation |
| Helical Titanium Tack FixationFixation of the polypropylene mesh using multiple helical titanium tacks ( ProTack®). The tacks are fired laparoscopically around the periphery of the mesh, penetrating the abdominal wall to mechanically secure the mesh in place, while avoiding anatomical danger zones. | Device | Tack Mesh Fixation |
| Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .All participants in this study will undergo Laparoscopic Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia, which is the standard surgical procedure. This minimally invasive technique involves: Creation of Pneumoperitoneum: The abdominal cavity is inflated with carbon dioxide gas. Port Placement: Three small incisions are made for camera and instrument ports. Peritoneal Incision: The peritoneum (inner abdominal lining) is cut to access the preperitoneal space in the groin. Hernia Reduction: The hernia sac and contents are pushed back into the abdominal cavity. Mesh Placement: A synthetic polypropylene mesh is positioned to cover the entire myopectineal orifice (the weak area where hernias occur). Mesh Fixation: The mesh is secured using one of three study methods (glue, sutures, or tacks) according to the assigned intervention arm. Peritoneal Closure: The initial peritoneal incision is closed over the mesh to isolate it from the abdominal organs. | Procedure or surgery | Glue Mesh Fixation, Suture Mesh Fixation, Tack Mesh Fixation |
Primary outcome
Postoperative Pain Intensity
Time frame: Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively.
Intensity of pain measured using the Visual Analogue Scale (VAS), a 10-point scale where 0 = no pain and 10 = worst pain imaginable.
Postoperative Quality of Life and Mesh Sensation
Time frame: Assessed at 1 month, 3 months, and 6 months postoperatively.
Patient-reported quality of life and mesh-related symptoms were measured using the Carolinas Comfort Scale (CCS), a validated hernia-specific outcome measure. The CCS consists of 23 items evaluating pain, mesh sensation, and movement limitation during daily activities, each scored from 0 (no symptoms) to 5 (disabling symptoms), yielding a total score range of 0-115. Higher scores indicate worse postoperative comfort and quality of life.
Operative Time
Time frame: Recorded on the day of surgery.
Total duration of surgery, measured from skin incision to skin closure (in minutes).
5 secondary outcomes
Hernia Recurrence
Time frame: Assessed at 6 months postoperatively.
Time to Return to Work/Normal Activity
Time frame: Assessed within the first 4 weeks postoperatively.
Length of Hospital Stay
Time frame: Measured during the immediate postoperative period (typically 1-2 days).
Postoperative Complications
Time frame: Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively
Direct Material Cost of Mesh Fixation Device
Time frame: Recorded on the day of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Derived from this study: PubMed 42265662Aziz AE, Khalil AH, Abdelnasser A, Elmonim AMA. Early postoperative pain and quality of life with different modalities of mesh fixation in laparoscopic trans-abdominal pre-peritoneal repair of inguinal hernia: a randomized controlled trial. BMC Surg. 2026 Jun 9;26(1):377. doi: 10.1186/s12893-026-03801-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Eid Aziz principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyanoacrylate Surgical Adhesive Fixation, Suture Mesh Fixation and Helical Titanium Tack Fixation in people with Inguinal Hernia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.