Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959904
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Surgery--Complications Procedure: Small stitch Other: Blood sample Other: Tissue Sample Other: Pain Score Other: Quality of Life Score Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups randomised to different suturing techniques following surgery
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Small Stitch
Small stitch for wound closure
Procedure: Small stitch
Wound closure will be using small stiches or larger spaced stitches
Other Name: Large Stitch

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

Other: Tissue Sample
A tissue sample will be taken to measure markers of wound healing.

Other: Pain Score
A pain score will be recorded following the surgical procedure.

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

Active Comparator: Large Stitch
Large Stitch for wound closure
Procedure: Small stitch
Wound closure will be using small stiches or larger spaced stitches
Other Name: Large Stitch

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

Other: Tissue Sample
A tissue sample will be taken to measure markers of wound healing.

Other: Pain Score
A pain score will be recorded following the surgical procedure.

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




Primary Outcome Measures :
  1. Hernia [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of Complications [ Time Frame: 1 year ]
    Incidence of post-operative complications at 6 months post op (burst abdomen, chest infection, surgical site infection, returns to theatre).

  2. Pain Scores [ Time Frame: 1 week 6 months and 12 months ]
    The level of pain as assessed by a pain score.

  3. Length of Stay in Hospital following surgery [ Time Frame: Number of days in hospital in 12 months post operation ]
    The number of days in hospital

  4. Quality of Life Post surgery [ Time Frame: 1 week 6 months 12 months post surgery ]
    A quality of life questionnaire will be administered.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959904


Contacts
Layout table for location contacts
Contact: Alex Shaw +441617012066 ext 12066 alex.shaw@mft.nhs.uk
Contact: Angela Summers, PhD +441617012066 ext 12066 angela.summers@mft.nhs.uk

Sponsors and Collaborators
Manchester University NHS Foundation Trust

Layout table for additonal information
Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03959904     History of Changes
Other Study ID Numbers: B00469
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Incisional Hernia
Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes