The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation

NCT03959904 | Recruiting DMC

• 1 other identifier: B00469
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY SUMMARY Incisional hernias, or swellings of the abdominal scar after surgery, remain problematic especially after transplant surgery. This is because they can cause complications, including trapping of bowel or the transplant. This can cause life threatening emergencies but is at the very least unsightly and uncomfortable for the patient. Transplant patients are especially likely to develop hernias because of the diseases causing the renal failure and the drugs that they take to dampen the immune system. There is evidence from other surgery that the stitching methods that are used to close the wounds might decrease the risk of surgical hernias. This is achieved by placing smaller and more numerous sutures (stitches) in the wound to increase the strength of the repair. However, this has never been tested formally in transplant where it may provide significant benefit. We intend to do some initial investigation of whether using the smaller stitches may provide benefit over more traditional methods that are currently being used. We will look at early complications after surgery but also the rate of hernia formation later. We hope to improve outcomes and reduce complications for our transplant patients by doing this. In addition we will collect blood and tissue samples from both live kidney donors and the recipients to microscopically analyse their collagen to identify potential factors which may indicate risk of hernia formation.

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Hernia

  Incidence of Incisional Hernia within one year post transplant, either clinically or radiologically detected. Any incisional hernia identified will be classified as per European Hernia Society Guidelines.

  1 year

Secondary Outcomes (4)

• Number of Complications

  1 year

• Pain Scores

  1 week 6 months and 12 months

• Length of Stay in Hospital following surgery

  Number of days in hospital in 12 months post operation

• Quality of Life Post surgery

  1 week 6 months 12 months post surgery

Study Arms (2)

Small Stitch

ACTIVE COMPARATOR

Small stitch for wound closure

Procedure: Small stitch; Other: Blood sample; Other: Tissue Sample; Other: Pain Score; Other: Quality of Life Score

Large Stitch

ACTIVE COMPARATOR

Large Stitch for wound closure

Procedure: Small stitch; Other: Blood sample; Other: Tissue Sample; Other: Pain Score; Other: Quality of Life Score

Interventions

Small stitch PROCEDURE

Wound closure will be using small stiches or larger spaced stitches

Also known as: Large Stitch

Large Stitch; Small Stitch

Blood sample OTHER

A blood sample to look for biological markers of Hernia formation will be taken

Large Stitch; Small Stitch

Tissue Sample OTHER

A tissue sample will be taken to measure markers of wound healing.

Large Stitch; Small Stitch

Pain Score OTHER

A pain score will be recorded following the surgical procedure.

Large Stitch; Small Stitch

Quality of Life Score OTHER

A Quality of Life Score will be recorded at 1 month 6 months and 12 months post surgery

Large Stitch; Small Stitch

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage renal failure patients
• Aged 18-70yrs
• First transplants or second transplants
• Ability to adequately understand English and consent for study
• BMI\<35 kg/m2)

You may not qualify if:

• Outside age range,
• Previous transplants which have left a scar in the ilia fossa

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection; Histocompatibility Testing

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Immunologic Techniques

Central Study Contacts

Alex Shaw

CONTACT

+441617012066; alex.shaw@mft.nhs.uk

Angela Summers, PhD

CONTACT

+441617012066; angela.summers@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 2 groups randomised to different suturing techniques following surgery

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 22, 2019
• Study Start: March 10, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)