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临床试验/NCT03959904
NCT03959904招募中不适用

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

Manchester University NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Hernia

研究概览

简要总结

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.

详细描述

Study Design This study has two phases. In phase 1 we will perform a retrospective review of hernia incidence in our centre over the last decade. We will seek to identify risk factors in our transplant cohort. In phase 2 we will perform a prospective randomised blinded feasibility trial in which the conventional large bites technique will be compared with the small bites technique.

STUDY SETTING The study will be carried out on one site at Manchester Royal Infirmary, part of Manchester University National Health Service (NHS) Foundation Trust. This is a regional Renal and Pancreas Transplant centre performing approximately 60 pancreas transplants per annum and 350 kidney transplants. All members of the team have academic track records and participate in several on-going research projects. Current research projects are investigating cardiovascular disease, kidney perfusion, Magnetic Resonance (MR) imaging to name a few.

RESEARCH QUESTIONS, AIMS, AND OBJECTIVES

Phase 1 To retrospectively evaluate the incidence of incisional hernias in our transplant population and associated risk factors.

Phase 2

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • Living donor nephrectomy patients Exclusion Criteria
  • Outside age range,
  • Previous transplants which have left a scar in the ilia fossa

排除标准

  • 未提供

结局指标

主要结局

Hernia

时间窗: 1 year

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.

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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