Prevention of Incisional Hernia After Renal Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About this trial
Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Candidate for first kidney transplant
Disqualifiers
Patient receiving a second or successive renal transplant.
Trial design
Design model
Parallel
Treatments tested in this trial
ProGrip™ Self-Gripping Polyester Mesh
DeviceSupra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: ProGrip® Mesh reinforcementActive comparator 1 intervention
Group B: Monomax® USP 0 2 planes closureNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT)
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT) of incisional hernia at 2 years post-transplantation.
Time frame
24 monthsSecondary outcomes
1
To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation
To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation measured by determining the incidence of surgical wound complications: number of seromas, number of surgical wound infections, incidence and severity of acute and chronic pain, and need for mesh removal.
Time frame
3, 6, 12 and 24 monthsOther outcomes
1
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by the reduction in the incidence of incisional hernia at 2 years post-transplantation measured by radiological diagnosis (CT)
Reduction in the incidence of incisional hernia at 2 years post-transplantation.
Time frame
24 months2
To determine the incidence of incisional hernia surgery in post-renal transplantation measured by physical examination at 3, 6 and 12 months and by radiological diagnosis (CT) at 24 months
To determine the incidence of incisional hernia surgery in post-renal transplantation.
Time frame
3, 6, 12 and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov