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Inguinal HerniaNCT05655988

MESH MIGRATION IN TOTAL EXTRAPERITONEAL INGUINAL HERNI REPAIR

A study testing inguinal ultrasonography in people with Inguinal Hernia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Inguinal henri repair is among the most common operations performed by general surgery. The use of laparoscopy in inguinal hernia repair is becoming more common day by day. Laparoscopic inguinal hernia repair is being applied with increasing frequency due to its advantages such as reducing postoperative pain… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inguinal Hernia
What is being tested?
inguinal ultrasonography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2022to 15 Jan 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years. patients who have not had previous inguinal region surgery. Patients with a direct and/or indirect hernia smaller than 5 cm.

Who cannot join

  • Complicated hernias. Patients undergoing mesh fixation for any reason. Patients with hemorrhage greater than 200 cc during or after surgery. Patients with drains. Patients with complications such as bleeding, early recurrence, wound infection in the early postoperative period.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Research and Training Hospital

    Istanbul, 34734

    anıl ergin, +902165783000, dranilergin@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: EVALUATION OF MESH MIGRATION THAT DO NOT REQUIRE FIXATION IN TOTAL EXTRAPERITONEAL INGUINAL HERNI REPAIR

Inguinal henri repair is among the most common operations performed by general surgery. The use of laparoscopy in inguinal hernia repair is becoming more common day by day. Laparoscopic inguinal hernia repair is being applied with increasing frequency due to its advantages such as reducing postoperative pain, providing early return to work and increasing patient satisfaction. Due to the widespread use of laparoscopic inguinal hernia repair, the best fixation method for the patches has become an increasingly questionable subject. It is thought that fixation of the patch with staples or clips may reduce the slippage of the patch, thus reducing the risk of hernia recurrence. In addition, it has been stated that the use of these fixation materials will both increase the cost and cause acute and chronic pain after surgery. In some studies in the literature, it was determined that not detecting the patch in laparoscopic inguinal hernia repair did not increase the recurrence. There are some studies showing that failure to fix the patch causes patch slippage in unilateral laparoscopic inguinal hernia repair. In this study, it was planned to investigate the rate of displacement of the patches fixed with staples in patches that do not require fixation in laparoscopic inguinal hernia repair surgeries, compared to the ones that were not fixed, and whether they cause recurrence. At the same time, whether the staples used for patch fixation increase postoperative pain will be evaluated with VAS (visual analog scale) at the postoperative 1st day, 1st month and 6th month after the operation, compared to the group without stapler patch fixation.

Read the detailed description

72 patients who underwent laparoscopic inguinal hernia repair (Total Extraperitoneal repair) for unilateral inguinal hernia in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included in the study. The number of samples was calculated by performing impact power analysis. Informed consent form and voluntary consent form will be obtained from all patients.

A fixation-free patch (Medtronic Dextile Anatomical mesh, USA) will be used in all patients and the patients will be divided into 2 groups containing 36 patients. 1 patch fixation stapler will be placed on the pubic protrusion in the first group (Covidien ProTack Fixation Device 5mm, USA), no fixation material will be used in the second group. Randomization will be provided by determining which patient will be included in which group on the website www.randomiser.org. In all patients, 2 metallic clips (Covidien Endo Clip II Auto suture, USA) will be placed on the superomedial and inferomedial patch borders on the placed mesh, and patch slippage will be evaluated by determining the locations of the clips by superficial ultrasonography at the end of the surgery, at the 1st and 6th months after the surgery. Superficial USG will be performed by the researchers and no expense will be charged to the SSI. Visual Analogue Scale pain assessment questionnaire will be applied to all patients in the postoperative period and the results will be recorded. Patients will be evaluated in terms of inguinal hernia type (direct, indirect), age, gender, hernia size, previous lower abdomen surgery, and additional diseases. The surgeon and the patient performing the ultrasonographic evaluation will not know in which cases the patch has been detected, so the study will be designed as double-blind.

Patients with contraindicated general anesthesia, previous lower abdominal surgery, coagulopathy, iguinoscrotal hernia, incarcerated or strangulated hernia, with a lateral-medial hernia greater than 3 cm and a drain placed will not be included in the study.

Surgical technique: After the infraumbilical 1 cm camera trocar is placed, 2 5 mm working trocars will be inserted through the line alba. After the CO2 insufflation, a 30° camera will be used and the surgery will be performed under 12 mmHg CO2 pressure. After opening the preperitoneal area with the help of blunt dissection, the hernia sac will be clearly revealed and released. All patients will be evaluated peroperatively for the presence of direct and indirect hernia, by clearly demonstrating the spermatic cord structures and normal anatomy. Then, a fixation-free patch (Medtronic Dextile Anatomical Mesh, USA) will be placed on the defect area and fixed on the pubis in one group and not fixed in the other group. It will be ensured that the patch overflows at least 3-4 cm from the defect area. Before the patch is placed in the preperitoneal area, 3 pieces of 10 mm Medium Endo Clips (Covidien Endo Clip II Auto suture, USA) will be placed on the superomedial, inferolateral and inferomedial border. Then, after bleeding control, the layers will be closed in accordance with their anatomy.

The distances between the 3 clips placed at the end of the operation will be measured vertically and horizontally by USG and recorded as x and y values. Ultrasonographic evaluations of the patient will be performed by a surgeon trained in inguinal region Ultrasound.

During the statistical analysis, Mann-Whitney U, Student's T test, Pearson's Chi Square test and Fisher's test will be used where appropriate. Statistically significant p value will be taken into account when it is greater than 0.05.

Conditions
Inguinal Hernia
Being tested
inguinal ultrasonography
Keywords
inguinal hernia, total extraperitoneal hernia repair, mesh migration, laparoscopic 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.

  • inguinal ultrasonographyDiagnostic test

    After a total extraperitoneal inguinal hernia operation performed using a fixation-free mesh, ultrasonography will be performed on all patients to calculate the slip size of the mesh.

Study groups in NCT05655988
Study groupRoleWhat they receive
mesh migration after TEPP / fixation free meshActive comparatorAfter a total extraperitoneal inguinal hernia operation performed using a fixation-free mesh, ultrasonography will be performed on all patients to calculate the slip size of the mesh.
Receives: Diagnostic Test: inguinal ultrasonography
mesh migration after TEPP / mesh with fixationActive comparatorTEPP surgeries performed with mesh fixation
Receives: Diagnostic Test: inguinal ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mesh migration

    Deciding whether these meshes really require detection based on the extent of migration in non-detection meshes.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start15 Dec 2022 (estimated)
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Jan 2024 (estimated)

Resources

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
After a total extraperitoneal inguinal hernia operation performed using a fixation-free mesh, ultrasonography will be performed on all patients to calculate the slip size of the mesh.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05655988
Sponsor's protocol ID
ANILLERGİNNN
Status last verified
Dec 2022
First submitted
9 Dec 2022
Last updated
19 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Patient data can be shared upon request.

Questions about this trial

What is this clinical trial studying?

A study testing inguinal ultrasonography in people with Inguinal Hernia, run by Fatih Sultan Mehmet Training and Research Hospital 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 1 inclusion and 1 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 19 Dec 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ANIL ERGİN (+905342245364, dranilergin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mesh migration (time frame: 1 year). 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 19 Dec 2022.

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