Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial.
Victoria Gómez-Dos-Santos, José Antonio López-Plaza, José Manuel Molina-Villar...
https://pubmed.ncbi.nlm.nih.gov/37580782Actively Recruiting
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2024-11-22
160
Participants Needed
1
Research Sites
N/A
Total Duration
F
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead Sponsor
M
Medtronic
Collaborating Sponsor
Researchers are evaluating the effectiveness of mesh reinforcement in closing the abdominal incision after kidney transplantation to reduce the chance of developing incisional hernias within 2 years after surgery. Incisional hernias are defects or bulges at the surgical scar site that can cause complications and may require further surgery. This study focuses on kidney transplant patients who face higher hernia risks due to immunosuppressive treatments and other factors like obesity and female sex. The trial compares two methods of closing the surgical wound: one group receives a self-gripping polyester mesh called ProGrip placed above the muscle layer to reinforce the closure without additional stitches. The control group has the incision closed using a standard two-layer suture technique with long-lasting absorbable thread. Both groups have a small drain placed under the skin after surgery to remove fluids for a few days. Participants will be followed for 24 months after their transplant, with check-ups at 3, 6, 12, and 24 months. These visits include physical exams, lab tests, monitoring for side effects, and a CT scan at the end of the study to detect hernias. The study aims to measure how well the mesh prevents hernias and to assess the safety of this approach. A total of 160 adult first-time kidney transplant recipients will take part, with obesity being considered in how participants are assigned to groups.
CONDITIONS
Prevention of Incisional Hernia After Renal Transplantation
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay until post-transplant day 2 or 3
Participants undergo kidney transplantation surgery with either mesh reinforcement or standard closure, followed by immediate post-operative care including placement and removal of a subcutaneous drain.
1 surgical procedure and hospital stay with drain removal on day 2 or 3
Duration - 24 months after surgery
Participants have clinical visits including physical examination, laboratory tests, and monitoring for adverse effects at 3, 6, 12, and 24 months after surgery. The final evaluation at 24 months includes a radiological examination (CT scan) to assess the presence of incisional hernia.
Clinical visits at 3, 6, 12, and 24 months including physical exams and tests; 1 radiological exam at 24 months
Total: 1 location
1
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
G
GOMEZ
B
BURGOS
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Victoria Gómez-Dos-Santos, José Antonio López-Plaza, José Manuel Molina-Villar...
https://pubmed.ncbi.nlm.nih.gov/37580782