Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia

Parastomal Hernia Clinical Trial

— StoKo  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02489175
• Other study ID #: 202/15
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2018
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of Baden	Baden
Switzerland	University Hospital of Basel	Basel
Switzerland	University Hospital of Geneva	Geneva
Switzerland	University Hospital of Lausanne	Lausanne
Switzerland	Cantonal Hospital of Schaffhausen	Schaffhausen
Switzerland	Limmattal Spital	Schlieren
Switzerland	University Hospital of Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Nicolas DEMARTINES

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Cheung MT. Complications of an abdominal stoma: an analysis of 322 stomas. Aust N Z J Surg. 1995 Nov;65(11):808-11. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Jänes 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. — View Citation

Jänes 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. — View Citation

Londono-Schimmer EE, Leong AP, Phillips RK. Life table analysis of stomal complications following colostomy. Dis Colon Rectum. 1994 Sep;37(9):916-20. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parastomal hernia rate	evaluated by abdominal CT and clinical examination, number of patients with parastomal hernia	at 12 months
Secondary	Stoma necrosis	Evaluated by clinical examination, number of patients with stoma necrosis	30 postoperative days, 12 and 24 months
Secondary	Stoma retraction	Evaluated by clinical examination, number of patients with stoma retraction	30 postoperative days, 12 and 24 months
Secondary	Surgical site infection	Evaluated by clinical examination, number of patients with surgical site infection	30 postoperative days, 12 and 24 months