- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05655988
MESH MIGRATION IN TOTAL EXTRAPERITONEAL INGUINAL HERNI REPAIR
EVALUATION OF MESH MIGRATION THAT DO NOT REQUIRE FIXATION IN TOTAL EXTRAPERITONEAL INGUINAL HERNI REPAIR
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ANIL ERGİN
- Phone Number: +905342245364
- Email: dranilergin@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34734
- Fatih Sultan Mehmet Research and Training Hospital
-
Contact:
- anıl ergin
- Phone Number: +902165783000
- Email: dranilergin@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: mesh migration after TEPP / fixation free mesh
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.
|
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.
|
Active Comparator: mesh migration after TEPP / mesh with fixation
TEPP surgeries performed with mesh fixation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mesh migration
Time Frame: 1 year
|
Deciding whether these meshes really require detection based on the extent of migration in non-detection meshes.
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANILLERGİNNN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inguinal Hernia
-
Children's Mercy Hospital Kansas CityRecruitingInguinal Hernia | Inguinal Hernia, Indirect | Inguinal Hernia Unilateral | Inguinal Hernia BilateralUnited States
-
Hospital General Universitario ElcheCompletedInguinal Hernia | Inguinal Hernia Repair | Open Inguinal Hernia
-
San Bonifacio HospitalCompletedIndirect Inguinal Hernia | Direct Inguinal HerniaItaly
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalEnrolling by invitationInguinal Hernia | Strangulated Inguinal Hernia | Incarcerated Inguinal HerniaTurkey
-
University Hospital, GhentMedriCompleted
-
Ahmadullah DanishCompletedIncarcerated Inguinal HerniaAfghanistan
-
General Hospital of LarissaUnknown
-
Alexandria UniversityCompletedBilateral Inguinal Hernia
-
Hospital Siberia-SerenaUnknownPrimary Inguinal HerniaSpain
-
Diskapi Teaching and Research HospitalCompleted
Clinical Trials on inguinal ultrasonography
-
Melanoma and Skin Cancer Trials LimitedMelanoma Institute Australia; Cancer Council New South WalesActive, not recruitingMetastatic Melanoma to the Groin Lymph NodesUnited Kingdom, Slovenia, Australia, Brazil, Netherlands, Italy
-
The Cleveland ClinicCompleted
-
Mount Sinai Hospital, CanadaMcGill University; McMaster University; Dalhousie UniversityTerminatedMale Infertility | VaricocelesCanada
-
University College, LondonNorfolk and Norwich University Hospitals NHS Foundation Trust; The Christie... and other collaboratorsRecruitingMelanoma | Penile Cancer | Inguinal LymphadenopathyUnited Kingdom
-
Algemeen Ziekenhuis Maria MiddelaresCompletedInguinal HerniaBelgium
-
Ann & Robert H Lurie Children's Hospital of ChicagoJohns Hopkins UniversityCompletedInguinal HerniaUnited States
-
The Sydney Hernia Specialists ClinicUniversity of SydneyCompletedInguinal HerniaAustralia
-
General Hospital of LarissaUnknown
-
Akdeniz UniversityCompleted
-
University Hospital, CataniaUnknown