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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorManchester University NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

End-stage renal failure patients

Aged 18-70yrs

First transplants or second transplants

Ability to adequately understand English and consent for study

Disqualifiers

Outside age range,

Previous transplants which have left a scar in the ilia fossa

Trial design

Design model

Parallel

Treatments tested in this trial

  • Small stitch

    Procedure/Surgery

    Wound closure will be using small stiches or larger spaced stitches

  • Blood sample

    Other intervention

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

  • Tissue Sample

    Other intervention

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

  • Pain Score

    Other intervention

    A pain score will be recorded following the surgical procedure.

  • Quality of Life Score

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Small StitchActive comparator 5 interventions
Group B: Large StitchActive comparator 5 interventions

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

Number of Complications

Incidence of post-operative complications at 6 months post op (burst abdomen, chest infection, surgical site infection, returns to theatre).

Time frame
1 year
2

Pain Scores

The level of pain as assessed by a pain score.

Time frame
1 week 6 months and 12 months
3

Length of Stay in Hospital following surgery

The number of days in hospital

Time frame
Number of days in hospital in 12 months post operation
4

Quality of Life Post surgery

A quality of life questionnaire will be administered.

Time frame
1 week 6 months 12 months post surgery

Other outcomes

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