Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia (StoKo)

October 22, 2018 updated by: Nicolas DEMARTINES

International Prospective Randomized Multicenter Trial to Analyze the Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia

Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impact on patients' quality of life. Half of the stomas created each year are permanent and up to 50% of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- or colostomy. End colostomy carries the highest risk for PSH (48%). PSH lead to recurrent pain, poor fitting appliance with leakage and therefore, skin irritation, and can also be complicated by strangulation or occlusion. The literature reports that 30% of patients with a PSH will require surgery. There are many different surgical procedures to repair PSH: primary fascia repair, relocation of the stoma or repair with various type of mesh. Despite the efforts done to improve the techniques, the incidence of recurrent PSH is up to 70% dependent of the used technique. Therefore, the idea of implanting a mesh at the time of initial stoma formation has lately been advocated. A new device, the KoringKM, which is a stomaplasty ring made of propylene, flexible and non-absorbable, was created. This study will try to prove that incorporation of the new stomaplasty ring at the time of stoma creation will diminish long-term PSH rate. This hypothesis will improve patient's quality of life and reduce costs associated with PSH.

All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease and fulfilling the inclusion criteria are eligible to participate in the trial. The patients will be randomized 24 to 48 hours prior to surgery after given written informed consent. The implantation of the Koring will be perfomed by experienced surgeons (expertise based, best team approach) who have already implanted the Koring (e.g. participated in the observational study) and/or have reviewed the video documentation. The surgeon will fill out the first form with the data of the patient and of the surgical procedure. The surgical wound will be daily examined. A second form will be fill out during the 30 post-operative days visit. The patients will be asked to inform the surgeon and/or investigator if any side event or suspicion of infection occurs after hospital discharge. The next follow-up visits will be at one and two years including a clinical examination and an abdominal CT. At this moment, the 3rd and 4th forms will be documented. All data will be anonymised and included in an Excel database.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Baden, Switzerland, 5404
        • Cantonal Hospital of Baden
      • Basel, Switzerland, 4031
        • University Hospital of Basel
      • Geneva, Switzerland, 1211
        • University Hospital of Geneva
      • Lausanne, Switzerland, 1011
        • University Hospital of Lausanne
      • Schaffhausen, Switzerland, 8208
        • Cantonal Hospital of Schaffhausen
      • Schlieren, Switzerland, 8952
        • Limmattal Spital
      • Zürich, Switzerland, 8091
        • University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring permanent ostomy (ileo- or colostomy) for a malignant tumour with at least one year life expectancy
  • Patient is able to cooperate
  • Patient has given written informed consent
  • Age equal or greater than 18 years

Exclusion Criteria:

  • Life expectancy < 1 year
  • Palliative surgery
  • Benign disease
  • Factors impacting on the ability to cooperate
  • Mental disorders
  • Pregnant or breastfeeding women
  • Participation in another intervention trial with interference of intervention and outcome of this study
  • BMI < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stomaplasty KoringTM group
The KoringTM is a stomaplasty ring made of propylene, flexible and non-absorbable. It is fixed to the anterior sheath of the abdominal wall in order to prevent PSH.
Device: Stomaplasty KoringTM
In these patients, the stomaplasty Koring will be implanted at the time of the primary definitive stoma creation. The implantation of the Koring will be performed by experienced surgeons (expertise based, best team approach) who have already implanted the Koring (e.g. participated in the observational study) and/or have reviewed the video documentation. To ensure standardization for all participating centres an operative manual with standardized video sequences is available.
NO_INTERVENTION: No preventive measure
In these patients, the stoma creation will be traditional, with no mesh implanted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parastomal hernia rate
Time Frame: at 12 months
evaluated by abdominal CT and clinical examination, number of patients with parastomal hernia
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stoma necrosis
Time Frame: 30 postoperative days, 12 and 24 months
Evaluated by clinical examination, number of patients with stoma necrosis
30 postoperative days, 12 and 24 months
Stoma retraction
Time Frame: 30 postoperative days, 12 and 24 months
Evaluated by clinical examination, number of patients with stoma retraction
30 postoperative days, 12 and 24 months
Surgical site infection
Time Frame: 30 postoperative days, 12 and 24 months
Evaluated by clinical examination, number of patients with surgical site infection
30 postoperative days, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolas DEMARTINES

Investigators

  • Principal Investigator: Dieter Hahnloser, Professor, Centre Hospitalier Universitaire Vaudois (CHUV)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (ESTIMATE)

July 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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