Actively Recruiting
The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation
Led by Manchester University NHS Foundation Trust · Updated on 2025-05-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of different abdominal wall closure techniques on the occurrence of incisional hernias in patients undergoing kidney transplantation. Incisional hernias, which are swellings at the site of surgical scars, can cause serious complications, especially for transplant patients who are at higher risk due to their underlying conditions and immunosuppressive medications. This study aims to assess whether using smaller, more frequent stitches reduces hernia formation compared to traditional larger stitches, with the goal of improving outcomes and reducing complications after transplant surgery. The study has two phases. The first phase involves a retrospective review of hernia cases over the past decade to identify risk factors. The second phase is a prospective, randomized, double-blinded trial comparing the small stitches technique with the large stitches method for abdominal wound closure after kidney transplantation. Both kidney transplant recipients and living donor nephrectomy patients will be involved, with blood and tissue samples collected to study biological markers related to hernia risk. Quality of life and pain will also be assessed at various points after surgery. Participants will be monitored for one year after their transplant surgery. Researchers will evaluate the incidence of incisional hernias through clinical and radiological assessments, along with tracking post-operative complications, pain levels, length of hospital stay, and quality of life at one week, six months, and twelve months. Blood and tissue samples will be anonymized and analyzed for collagen and serum markers that might indicate hernia risk. The study is conducted at a single center and includes both retrospective data review and prospective clinical follow-up.
CONDITIONS
Brief Title
The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosis of end-stage renal failure
- Scheduled for first or second kidney transplant
- Ability to understand English and provide informed consent
- Body mass index (BMI) less than 35 kg/m2
- Living donor nephrectomy patients
You will not qualify if you...
- Outside the age range of 18 to 70 years
- Previous kidney transplants that have left a scar in the iliac fossa area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Hospital stay following surgery (days)
Participants undergo kidney transplantation surgery with abdominal wall closure using either the small stitch or large stitch technique. Tissue and blood samples are taken to investigate biological markers related to hernia formation.
1 surgical visit and hospital stay
Duration - Up to 12 months post-surgery
Participants have pain scores recorded and quality of life assessments at multiple time points to monitor recovery and complications after surgery.
Visits at 1 week, 6 months, and 12 months post surgery
Duration - 1 year
Participants are monitored for the incidence of incisional hernia and other complications up to one year following transplant surgery.
Follow-up visits for clinical and radiological assessments up to 1 year
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WU
Actively Recruiting
Research Team
A
Alex Shaw
A
Angela Summers, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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