Status:
NOT_YET_RECRUITING
Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair
Lead Sponsor:
Institut Catala de Salut
Conditions:
Ventral Incisional Hernia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK...
Detailed Description
Patients older than 18 years undergoing an elective ventral/incisional hernia laparoscopic repair with a hernia defect between 4-10cm of transversal defect The patients included are adults with a BMI ...
Eligibility Criteria
Inclusion
- All adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3)
- ASA grade from I-II
- Informed consent signed
Exclusion
- Patients less than 18 years and over 80 years of age.
- Fascial transverse defect less than 4 cm and more than 8 cm.
- Recurrent ventral or incisional hernia in the same place
- Emergency surgery
- Procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery)
- BMI greater than 35 Kg/m2
- ASA III-IV
- Pregnancy
- Tobacco
Key Trial Info
Start Date :
March 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06183840
Start Date
March 10 2024
End Date
December 31 2026
Last Update
March 6 2024
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