Inguinal HerniaNCT05152654
Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair
A study testing Tacker in people with Inguinal Hernia and Pain, Acute, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inguinal Hernia, Pain, Acute, Pain, Chronic
- What is being tested?
- Tacker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 31 Aug 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over 18 years old
- having a unilateral inguinal hernia
Who cannot join
- being under18 years old
- having comorbidity that prevents him from receiving general anesthesia
- having undergone previous lower abdominal surgery
- having previous surgery for inguinal hernia
- having bilateral inguinal hernia, scrotal hernia or strangulated hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair; Prospective Randomized Double-blinded Controlled Study
Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Until the last 20 years, after Lichtenstein described tension-free mesh hernia repair, this method was the gold standard in inguinal hernia surgery. This method was advantageous in terms of both less recurrence and less postoperative pain compared to tension methods. With the development of minimally invasive surgery, laparoscopic hernia surgery was first described by Dr. Ger in 1992. Laparoscopic inguinal hernia repair is based on the principles of preperitoneal repair described by Stoppa in open surgery. Its advantages over laparoscopic surgery are; Less post-operative pain, rapid recovery, reduction in nerve damage and chronic pain, and reduced recurrence rate. However, the disadvantage is that the learning curve is longer and higher cost. Two commonly used laparoscopic inguinal hernia surgeries are Trans Abdominal Pre-Peritoneal (TAPP) and totally extraperitoneal (TEP) methods. Although both are preperitoneal repair methods, less intraperitoneal organ damage, less intra-abdominal adhesion formation, and no need for peritoneal sheath repair are the advantages of the TEP method. For this reason, TEP method has been the preferred method today. Various methods have been tried in order not to change the location of the mesh placed in the TEP method. Laparoscopic inguinal hernia is one of the most debated issues. The most common methods for fixation are tacker, tissue adhesive, or suturing the mesh. However, fixing the mesh using a tacker can cause chronic pain. Tissue adhesives are not preferred because tissue adhesives have high costs and sometimes cause allergic reactions. The method in which the mesh is sewn to the pubic bone is avoided by surgeons because it prolongs the operation time. To avoid chronic pain after surgery, the idea was not to fix the mesh. The major drawback of this method is that the mesh may slip and cause recurrence.This study aimed to reveal the difference between the amount of migration and the amount of post-operative pain between detecting the mesh and not detecting it
Read the detailed description
The study will be conducted as a prospective, double-blind, randomized controlled study in the general surgery clinic of a university hospital. As a result of the power analysis calculated under Cohen's expert opinion, it was decided to include a total of 100 patients, 50 patients in order to reach 80% power with 0.50 effect size (medium effect) and 5% error (alpha=0.05). in each group. The study will continue by taking the consent of the patients and choosing from among the volunteer patients. The method by which the patients will be operated will be determined by choosing from a total of 100 (50 per group) sealed envelopes containing the group names. In the first (Fixation Group) group, inguinal hernia repair with the TEP method will be fixed with a mesh stapler. While inguinal hernia repair is performed with TEP method in the second (Non-Fixation Group) group, the mesh will not be fixed by any method. Exclusion criteria; It was determined as being younger than 18 years of age, having a comorbidity that prevented him from receiving general anesthesia, having had a previous lower abdominal surgery, having undergone previous inguinal hernia surgery, having bilateral inguinal hernia, scrotal hernia or strangulated hernia.
Creation of double blind; Patients will not be told which study group participants are in as a result of the envelope participants choose. In the postoperative follow-up of the patients, the researcher who recorded the parameters related to the study and provided the measurements will not know which group the patients are in.
Age, gender, comorbidity, smoking history and body mass index of the patients will be recorded on the preoperative forms. The surgery will be performed by a single surgeon according to the group chosen by the patients. The performing surgeon was a general surgeon with 5 years of active experience in laparoscopic hernia surgery and had performed both methods more than 200 times. Until the end of the study, only the surgeon will know which group the patients are in. The investigator evaluating the results of the study and the performing surgeon will not communicate about the study.
- Conditions
- Inguinal Hernia, Pain, Acute, Pain, Chronic
- Being tested
- Tacker
- Medical subject headings
- Hernia, Inguinal, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TackerDevice
metallic staples used to fix the mesh
| Study group | Role | What they receive |
|---|---|---|
| Fixation | No intervention | Total extra peritoneal repair will be performed in this arm for the patients due to unilateral inguinal hernia. The 15x12 cm mesh will be marked with titanium clips from its 4 corners and placed in the hernia area. The mesh will be fixed to the hernia area by the non-absorbable tacker.This method is the method used routinely in the treatment of laparoscopic hernia today. |
| Non-Fixation | Experimental | Total extra peritoneal repair will be performed in this arm for the patients due to unilateral inguinal hernia. The 15x12 cm mesh will be marked with titanium clips from its 4 corners and placed in the hernia area. The mesh will not be detected in any way. Receives: Device: Tacker |
What is being measured
The primary outcome is the main question the study is designed to answer.
displacement of the mesh one day after surgery
It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one day after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.
Measured: one day after surgery
displacement of the mesh one week after surgery
It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one week after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.
Measured: first week after surgery and 6th month after surgery
displacement of the mesh six month after surgery
It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken 6 months after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.
Measured: first week after surgery and 6th month after surgery
Postoperative 24th hours pain
Patients will be asked about their visual pain score at the postoperative 24th hour. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)
Measured: 24th hours after surgery
Postoperative 6th months pain
Patients will be asked about their visual pain score at 6 months postoperatively. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)
Measured: 6th month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- Patients participating in the study will be divided into two groups. Patients with unilateral inguinal hernia will be determined according to the envelope selection method. Patients will not know which group are in. The patients in the first group will be fixed with 5 tackers while performing total extraperitoneal repair. While the patients in the second group are performing total extraperitoneal repair, no fixation will be made while placing the mesh.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Baki YILDIRIM, Hitit University
- Investigators
- Murat B YILDIRIM, Principal investigator, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152654
- Sponsor's protocol ID
- Mesh fixation
- Status last verified
- Dec 2021
- First submitted
- 29 Sep 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.
PubMed 28214943Darwish A. A, Hegab A. A . Tack fixation versus nonfixation of mesh in laparoscopic transabdominal preperitonaeal hernia repair. Egyptian Journal of Surgery. 2016;35(4): 327-331. DOI: 10.4103/1110-1121.194729
Yildirim MB, Sahiner IT. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study. Hernia. 2023 Feb;27(1):63-70. doi: 10.1007/s10029-022-02587-w. Epub 2022 Mar 14.
PubMed 35286511
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair; Prospective Randomized Double-blinded Controlled Study
- ClinicalTrials.gov ID
- NCT05152654
- Acronym / sponsor ID
- Mesh fixation
- Conditions
- Inguinal Hernia, Pain, Acute, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 10 Dec 2021 (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.
Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Until the last 20 years, after Lichtenstein described tension-free mesh hernia repair, this method was the gold standard in inguinal hernia surgery. This method was advantageous in terms of both less recurrence and less postoperative pain compared to tension methods. With the development of minimally invasive surgery, laparoscopic hernia surgery was first described by Dr. Ger in 1992. Laparoscopic inguinal hernia repair is based on the principles of preperitoneal repair described by Stoppa in open surgery. Its advantages over laparoscopic surgery are; Less post-operative pain, rapid recovery, reduction in nerve damage and chronic pain, and reduced recurrence rate. However, the disadvantage is that the learning curve is longer and higher cost. Two commonly used laparoscopic inguinal hernia surgeries are Trans Abdominal Pre-Peritoneal (TAPP) and totally extraperitoneal (TEP) methods. Although both are preperitoneal repair methods, less intraperitoneal organ damage, less intra-abdominal adhesion formation, and no need for peritoneal sheath repair are the advantages of the TEP method. For this reason, TEP method has been the preferred method today. Various methods have been tried in order not to change the location of the mesh placed in the TEP method. Laparoscopic inguinal hernia is one of the most debated issues. The most common methods for fixation are tacker, tissue adhesive, or suturing the mesh. However, fixing the mesh using a tacker can cause chronic pain. Tissue adhesives are not preferred because tissue adhesives have high costs and sometimes cause allergic reactions. The method in which the mesh is sewn to the pubic bone is avoided by surgeons because it prolongs the operation time. To avoid chronic pain after surgery, the idea was not to fix the mesh. The major drawback of this method is that the mesh may slip and cause recurrence.This study aimed to reveal the difference between the amount of migration and the amount of post-operative pain between detecting the mesh and not detecting it
Detailed description
The study will be conducted as a prospective, double-blind, randomized controlled study in the general surgery clinic of a university hospital. As a result of the power analysis calculated under Cohen's expert opinion, it was decided to include a total of 100 patients, 50 patients in order to reach 80% power with 0.50 effect size (medium effect) and 5% error (alpha=0.05). in each group. The study will continue by taking the consent of the patients and choosing from among the volunteer patients. The method by which the patients will be operated will be determined by choosing from a total of 100 (50 per group) sealed envelopes containing the group names. In the first (Fixation Group) group, inguinal hernia repair with the TEP method will be fixed with a mesh stapler. While inguinal hernia repair is performed with TEP method in the second (Non-Fixation Group) group, the mesh will not be fixed by any method. Exclusion criteria; It was determined as being younger than 18 years of age, having a comorbidity that prevented him from receiving general anesthesia, having had a previous lower abdominal surgery, having undergone previous inguinal hernia surgery, having bilateral inguinal hernia, scrotal hernia or strangulated hernia.
Creation of double blind; Patients will not be told which study group participants are in as a result of the envelope participants choose. In the postoperative follow-up of the patients, the researcher who recorded the parameters related to the study and provided the measurements will not know which group the patients are in.
Age, gender, comorbidity, smoking history and body mass index of the patients will be recorded on the preoperative forms. The surgery will be performed by a single surgeon according to the group chosen by the patients. The performing surgeon was a general surgeon with 5 years of active experience in laparoscopic hernia surgery and had performed both methods more than 200 times. Until the end of the study, only the surgeon will know which group the patients are in. The investigator evaluating the results of the study and the performing surgeon will not communicate about the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Patients participating in the study will be divided into two groups. Patients with unilateral inguinal hernia will be determined according to the envelope selection method. Patients will not know which group are in. The patients in the first group will be fixed with 5 tackers while performing total extraperitoneal repair. While the patients in the second group are performing total extraperitoneal repair, no fixation will be made while placing the mesh.
| Arm | Type | Receives |
|---|---|---|
| Fixation | No intervention | –Total extra peritoneal repair will be performed in this arm for the patients due to unilateral inguinal hernia. The 15x12 cm mesh will be marked with titanium clips from its 4 corners and placed in the hernia area. The mesh will be fixed to the hernia area by the non-absorbable tacker.This method is the method used routinely in the treatment of laparoscopic hernia today. |
| Non-Fixation | Experimental | Device: TackerTotal extra peritoneal repair will be performed in this arm for the patients due to unilateral inguinal hernia. The 15x12 cm mesh will be marked with titanium clips from its 4 corners and placed in the hernia area. The mesh will not be detected in any way. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being over 18 years old
- having a unilateral inguinal hernia
Key exclusion criteria (5 listed)
- being under18 years old
- having comorbidity that prevents him from receiving general anesthesia
- having undergone previous lower abdominal surgery
- having previous surgery for inguinal hernia
- having bilateral inguinal hernia, scrotal hernia or strangulated hernia
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 |
|---|---|---|
| Tackermetallic staples used to fix the mesh | Device | Non-Fixation |
Primary outcome
displacement of the mesh one day after surgery
Time frame: one day after surgery
It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one day after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.
displacement of the mesh one week after surgery
Time frame: first week after surgery and 6th month after surgery
It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one week after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.
displacement of the mesh six month after surgery
Time frame: first week after surgery and 6th month after surgery
It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken 6 months after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.
Postoperative 24th hours pain
Time frame: 24th hours after surgery
Patients will be asked about their visual pain score at the postoperative 24th hour. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)
Postoperative 6th months pain
Time frame: 6th month after surgery
Patients will be asked about their visual pain score at 6 months postoperatively. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)
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 Dec 2021.
- Results publication: PubMed 28214943Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.
- Results publicationDarwish A. A, Hegab A. A . Tack fixation versus nonfixation of mesh in laparoscopic transabdominal preperitonaeal hernia repair. Egyptian Journal of Surgery. 2016;35(4): 327-331. DOI: 10.4103/1110-1121.194729
- Derived from this study: PubMed 35286511Yildirim MB, Sahiner IT. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study. Hernia. 2023 Feb;27(1):63-70. doi: 10.1007/s10029-022-02587-w. Epub 2022 Mar 14.
- 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.
Murat B YILDIRIM principal investigator
Hitit 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 Tacker in people with Inguinal Hernia and Pain, Acute, run by Hitit University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 Dec 2021. 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 Turkey (Türkiye). 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?
displacement of the mesh one day after surgery (time frame: one day after surgery). The study lists 5 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 NCT05152654, which also lists 3 linked publications.
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 Dec 2021.