Inguinal HerniaNCT06412445
Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Inguinal Hernia Repair
A study testing Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation and Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh in people with Inguinal Hernia, run by Helwan University at 1 site in Egypt.
Trial summary
The main objective of this study is to compare between the safety and efficacy of self-fixating mesh versus mesh fixation with tissue glue in patients undergoing laparoscopic transabdominal inguinal hernia repair (TAPP). The criteria of comparison shall include operating time, post-operative pain and recurrence. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation and Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to Jun 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral direct or indirect inguinal hernia
Who cannot join
- Bilateral hernia.
- Femoral hernia.
- Inguinoscrotal hernia.
- Complicated inguinal hernias.
- Recurrent inguinal hernias.
- Morbid obesity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Transabdominal Inguinal Hernia Repair: A Comparative Study
The main objective of this study is to compare between the safety and efficacy of self-fixating mesh versus mesh fixation with tissue glue in patients undergoing laparoscopic transabdominal inguinal hernia repair (TAPP). The criteria of comparison shall include operating time, post-operative pain and recurrence.
Read the detailed description
Inguinal hernia is the most common abdominal wall hernia. It is defined as a peritoneal sac protrusion through a weak point within the groin area. It often contains abdominal contents and is traditionally treated with surgery. Repair of inguinal hernia is one of the most commonly performed surgical procedures worldwide. Males are more commonly affected by inguinal hernia than females. The male to female ratio is approximately 9 to 1.
Whether to perform an open or a laparoscopic approach for inguinal hernia repair has always been a controversial issue. However, recent improvement in laparoscopic techniques has made it the procedure of choice in the opinion of most surgeons. Laparoscopic approach includes two main techniques, namely the total extra-peritoneal approach (TEP) and the trans abdominal pre-peritoneal approach (TAPP). However, TAPP has gained more popularity owing to its relative simplicity and easier reproducibility. TAPP involves standard laparoscopic approach with access into the peritoneal cavity and placement of a mesh along the anterior abdominal wall, thereby, repairing the hernia posterior to the defect.
During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs, the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment. Intraoperative strategies to reduce pain entail the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative pain.
By far, guidelines of the European Association for Endoscopic Surgery (EAES) and the European Hernia Society (EHS) reported no general evidence based consensus on the ideal tool for mesh fixation. Therefore, the choice often depends on surgeons personal preference, market availability and cost/benefit ratio. Recent advances in the biotechnology of mesh and mesh fixation industry lead to the production of innovative self-fixating meshes and alternatively meshes that are fixed with variable types of biomaterials and glue. Eventually, such tack free meshes are intended to reduce the rate of complications that might be attributed to tack bearing meshes. However, studies to evaluate the different tools of tack free mesh fixation techniques are still lacking.
- Conditions
- Inguinal Hernia
- Being tested
- Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation, Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh
- Keywords
- TAPP, Self-Fixating Mesh, Mesh Fixation, Tissue Glue, Laparoscopic Transabdominal Inguinal Hernia Repair, Inguinal Hernia Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixationProcedure or surgery
The operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving applying tissue glue for mesh fixation. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures.
Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating meshProcedure or surgery
Also called TAPP procedure
The operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving the adherence of grips to tissue using self-fixating mesh. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue | Active comparator | Patients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair having there mesh fixated with tissue glue. Glubran 2® surgical glue is a medical device Class III CE marked for internal and external use. It is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer synthesized by the manufacturer GEM. It is ready for use. It has high adhesive and haemostatic properties and once it is polymerised it creates an efficient antiseptic barrier against the most diffused infective or pathogenic agents during the surgical intervention. It polymerizes quickly in contact with live tissue and wet environment creating a thin and elastic film having high tensile properties which guarantee strong adhesion to the tissues. This film naturally conforms with the tissues on which it is applied; it is not permeable to liquids and is not altered by blood or organic liquids Receives: Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation |
| Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh | Active comparator | Patients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair with self fixating mesh. Covidien ProGrip mesh is a self-gripping polyester mesh, 15x15 cm in size, it is equipped with resorbable microgrip technology which provides immediate fixation of the entire mesh surface for a secure repair and even distribution of tension for patient comfort. The resorbable polylactic acid (PLA) microgrips enable surgeons to position and place the mesh in under 60 seconds, without the use of additional fixation. Surgeons and patients can depend on a secure repair with the potential for greater patient comfort. According to the manufacturer, the time for degradation of the quickly absorbing layer is < 1 day and that for the layer with microgrips > 18 months Receives: Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
clinical or radiological at any time point
Measured: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months
Chronic pain
pain persisting beyond three months postoperatively. Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain
Measured: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months
Secondary outcomes (8)
Length of surgery
in minutes
Measured: 1 to 3 hours
Immediate postoperative pain
Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain
Measured: 1 to 3 days
Vascular/visceral injury
Any visualized or reported vascular or visceral injury during the operation
Measured: 1 to 3 hours
Haematoma/seroma development
Haematoma or seroma development in postoperative period (Clinical or radiological)
Measured: 1 to 7 days
Length of hospital stay
in days
Measured: 1 to 7 days
Urinary retention
in immediate postoperative period
Measured: 1 to 2 days
Wound infection/mesh infection
at any time point
Measured: 1 to 30 days
Recovery time to normal activity
in days
Measured: 1 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Ashraf Maher Farid, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412445
- Sponsor's protocol ID
- Mesh Fixation Methods in TAPP
- Status last verified
- May 2024
- First submitted
- 3 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Transabdominal Inguinal Hernia Repair: A Comparative Study
- ClinicalTrials.gov ID
- NCT06412445
- Acronym / sponsor ID
- Mesh Fixation Methods in TAPP
- Conditions
- Inguinal Hernia
- Keywords
- TAPP, Self-Fixating Mesh, Mesh Fixation, Tissue Glue, Laparoscopic Transabdominal Inguinal Hernia Repair, Inguinal Hernia Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 14 May 2024 (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.
The main objective of this study is to compare between the safety and efficacy of self-fixating mesh versus mesh fixation with tissue glue in patients undergoing laparoscopic transabdominal inguinal hernia repair (TAPP). The criteria of comparison shall include operating time, post-operative pain and recurrence.
Detailed description
Inguinal hernia is the most common abdominal wall hernia. It is defined as a peritoneal sac protrusion through a weak point within the groin area. It often contains abdominal contents and is traditionally treated with surgery. Repair of inguinal hernia is one of the most commonly performed surgical procedures worldwide. Males are more commonly affected by inguinal hernia than females. The male to female ratio is approximately 9 to 1.
Whether to perform an open or a laparoscopic approach for inguinal hernia repair has always been a controversial issue. However, recent improvement in laparoscopic techniques has made it the procedure of choice in the opinion of most surgeons. Laparoscopic approach includes two main techniques, namely the total extra-peritoneal approach (TEP) and the trans abdominal pre-peritoneal approach (TAPP). However, TAPP has gained more popularity owing to its relative simplicity and easier reproducibility. TAPP involves standard laparoscopic approach with access into the peritoneal cavity and placement of a mesh along the anterior abdominal wall, thereby, repairing the hernia posterior to the defect.
During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs, the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment. Intraoperative strategies to reduce pain entail the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative pain.
By far, guidelines of the European Association for Endoscopic Surgery (EAES) and the European Hernia Society (EHS) reported no general evidence based consensus on the ideal tool for mesh fixation. Therefore, the choice often depends on surgeons personal preference, market availability and cost/benefit ratio. Recent advances in the biotechnology of mesh and mesh fixation industry lead to the production of innovative self-fixating meshes and alternatively meshes that are fixed with variable types of biomaterials and glue. Eventually, such tack free meshes are intended to reduce the rate of complications that might be attributed to tack bearing meshes. However, studies to evaluate the different tools of tack free mesh fixation techniques are still lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue | Active comparator | Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixationPatients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair having there mesh fixated with tissue glue. Glubran 2® surgical glue is a medical device Class III CE marked for internal and external use. It is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer synthesized by the manufacturer GEM. It is ready for use. It has high adhesive and haemostatic properties and once it is polymerised it creates an efficient antiseptic barrier against the most diffused infective or pathogenic agents during the surgical intervention. It polymerizes quickly in contact with live tissue and wet environment creating a thin and elastic film having high tensile properties which guarantee strong adhesion to the tissues. This film naturally conforms with the tissues on which it is applied; it is not permeable to liquids and is not altered by blood or organic liquids |
| Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh | Active comparator | Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating meshPatients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair with self fixating mesh. Covidien ProGrip mesh is a self-gripping polyester mesh, 15x15 cm in size, it is equipped with resorbable microgrip technology which provides immediate fixation of the entire mesh surface for a secure repair and even distribution of tension for patient comfort. The resorbable polylactic acid (PLA) microgrips enable surgeons to position and place the mesh in under 60 seconds, without the use of additional fixation. Surgeons and patients can depend on a secure repair with the potential for greater patient comfort. According to the manufacturer, the time for degradation of the quickly absorbing layer is < 1 day and that for the layer with microgrips > 18 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unilateral direct or indirect inguinal hernia
Key exclusion criteria (6 listed)
- Bilateral hernia.
- Femoral hernia.
- Inguinoscrotal hernia.
- Complicated inguinal hernias.
- Recurrent inguinal hernias.
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 |
|---|---|---|
| Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixationThe operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving applying tissue glue for mesh fixation. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures. | Procedure or surgery | Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue |
| Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating meshAlso: TAPP procedureThe operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving the adherence of grips to tissue using self-fixating mesh. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures. | Procedure or surgery | Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh |
Primary outcome
Hernia recurrence
Time frame: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months
clinical or radiological at any time point
Chronic pain
Time frame: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months
pain persisting beyond three months postoperatively. Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain
8 secondary outcomes
Length of surgery
Time frame: 1 to 3 hours
Immediate postoperative pain
Time frame: 1 to 3 days
Vascular/visceral injury
Time frame: 1 to 3 hours
Haematoma/seroma development
Time frame: 1 to 7 days
Length of hospital stay
Time frame: 1 to 7 days
Urinary retention
Time frame: 1 to 2 days
Wound infection/mesh infection
Time frame: 1 to 30 days
Recovery time to normal activity
Time frame: 1 to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation and Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh in people with Inguinal Hernia, run by Helwan 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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?
Results are not available in the source record.
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?
Hernia recurrence (time frame: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.