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

Sponsor

Nicolas DEMARTINES (Other)

Overall Status

Terminated

CT.gov ID

NCT02489175

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

0.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Parastomal Hernia	Device: Stomaplasty KoringTM	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Parastomal hernia rate [at 12 months]
evaluated by abdominal CT and clinical examination, number of patients with parastomal hernia

Secondary Outcome Measures

Stoma necrosis [30 postoperative days, 12 and 24 months]
Evaluated by clinical examination, number of patients with stoma necrosis
Stoma retraction [30 postoperative days, 12 and 24 months]
Evaluated by clinical examination, number of patients with stoma retraction
Surgical site infection [30 postoperative days, 12 and 24 months]
Evaluated by clinical examination, number of patients with surgical site infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cantonal Hospital of Baden	Baden	Switzerland	5404
2	University Hospital of Basel	Basel	Switzerland	4031
3	University Hospital of Geneva	Geneva	Switzerland	1211
4	University Hospital of Lausanne	Lausanne	Switzerland	1011
5	Cantonal Hospital of Schaffhausen	Schaffhausen	Switzerland	8208
6	Limmattal Spital	Schlieren	Switzerland	8952
7	University Hospital of Zürich	Zürich	Switzerland	8091