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Parastomal HerniaStoKoNCT02489175

Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia

A study testing Stomaplasty KoringTM in people with Parastomal Hernia, run by Nicolas DEMARTINES at 7 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parastomal Hernia
What is being tested?
Stomaplasty KoringTM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
7 sitesSwitzerland
Study dates
Jul 2015to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Switzerland7 sites

  • Cantonal Hospital of Baden

    Baden, 5404

  • University Hospital of Basel

    Basel, 4031

  • University Hospital of Geneva

    Geneva, 1211

  • University Hospital of Lausanne

    Lausanne, 1011

  • Cantonal Hospital of Schaffhausen

    Schaffhausen, 8208

  • Limmattal Spital

    Schlieren, 8952

  • University Hospital of Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Stomaplasty KoringTM
Keywords
Parastomal hernia, prevention, stomaplasty, ring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stomaplasty KoringTMDevice

    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.

Study groups in NCT02489175
Study groupRoleWhat they receive
Stomaplasty KoringTM groupExperimentalThe 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.
Receives: Device: Stomaplasty KoringTM
No preventive measureNo interventionIn these patients, the stoma creation will be traditional, with no mesh implanted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parastomal hernia rate

    evaluated by abdominal CT and clinical examination, number of patients with parastomal hernia

    Measured: at 12 months

Secondary outcomes (3)

  1. Stoma necrosis

    Evaluated by clinical examination, number of patients with stoma necrosis

    Measured: 30 postoperative days, 12 and 24 months

  2. Stoma retraction

    Evaluated by clinical examination, number of patients with stoma retraction

    Measured: 30 postoperative days, 12 and 24 months

  3. Surgical site infection

    Evaluated by clinical examination, number of patients with surgical site infection

    Measured: 30 postoperative days, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionOct 2015
  4. Study completionOct 2015

Why it stopped: The device used was removed from the market

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489175
Sponsor's protocol ID
202/15
Acronym
StoKo
Status last verified
Oct 2018
First submitted
17 Jun 2015
Last updated
24 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. doi: 10.1007/s10350-006-0681-4.

    PubMed 17120189

  • Londono-Schimmer EE, Leong AP, Phillips RK. Life table analysis of stomal complications following colostomy. Dis Colon Rectum. 1994 Sep;37(9):916-20. doi: 10.1007/BF02052598.

    PubMed 8076492

  • Shabbir J, Chaudhary BN, Dawson R. A systematic review on the use of prophylactic mesh during primary stoma formation to prevent parastomal hernia formation. Colorectal Dis. 2012 Aug;14(8):931-6. doi: 10.1111/j.1463-1318.2011.02835.x.

    PubMed 21929523

  • Cheung MT. Complications of an abdominal stoma: an analysis of 322 stomas. Aust N Z J Surg. 1995 Nov;65(11):808-11. doi: 10.1111/j.1445-2197.1995.tb00566.x.

    PubMed 7487732

  • Hoffmann H, Oertli D, Soysal S, Zingg U, Hahnloser D, Kirchhoff P. A promising new device for the prevention of parastomal hernia. Surg Innov. 2015 Jun;22(3):283-4. doi: 10.1177/1553350614560270. Epub 2014 Nov 27.

    PubMed 25432883

  • Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.

    PubMed 19011935

  • Hansson BM, Slater NJ, van der Velden AS, Groenewoud HM, Buyne OR, de Hingh IH, Bleichrodt RP. Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg. 2012 Apr;255(4):685-95. doi: 10.1097/SLA.0b013e31824b44b1.

    PubMed 22418006

  • Janes A, Cengiz Y, Israelsson LA. Experiences with a prophylactic mesh in 93 consecutive ostomies. World J Surg. 2010 Jul;34(7):1637-40. doi: 10.1007/s00268-010-0492-6.

    PubMed 20182719

Questions about this trial

What is this clinical trial studying?

A study testing Stomaplasty KoringTM in people with Parastomal Hernia, run by Nicolas DEMARTINES at 7 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The device used was removed from the market). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parastomal hernia rate (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02489175, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.

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