Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia

NCT02489175 | Terminated

• 1 other identifier: 202/15
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 7

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.

Conditions

Parastomal Hernia

Keywords

Parastomal hernia; prevention; stomaplasty; ring

Outcome Measures

Primary Outcomes (1)

• Parastomal hernia rate

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

  at 12 months

Secondary Outcomes (3)

• Stoma necrosis

  30 postoperative days, 12 and 24 months

• Stoma retraction

  30 postoperative days, 12 and 24 months

• Surgical site infection

  30 postoperative days, 12 and 24 months

Study Arms (2)

Stomaplasty KoringTM group

EXPERIMENTAL

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

No preventive measure

NO INTERVENTION

In these patients, the stoma creation will be traditional, with no mesh implanted

Interventions

Stomaplasty KoringTM DEVICE

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.

Stomaplasty KoringTM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolas DEMARTINES: lead

Study Sites (7)

Cantonal Hospital of Baden

Baden, 5404, Switzerland

Location

University Hospital of Basel

Basel, 4031, Switzerland

Location

University Hospital of Geneva

Geneva, 1211, Switzerland

Location

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Cantonal Hospital of Schaffhausen

Schaffhausen, 8208, Switzerland

Location

Limmattal Spital

Schlieren, 8952, Switzerland

Location

University Hospital of Zürich

Zurich, 8091, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 17120189 BACKGROUND

• 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.

  PMID: 8076492 BACKGROUND

• 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.

  PMID: 21929523 BACKGROUND

• 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.

  PMID: 7487732 BACKGROUND

• 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.

  PMID: 25432883 BACKGROUND

• 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.

  PMID: 19011935 BACKGROUND

• 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.

  PMID: 22418006 BACKGROUND

• 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.

  PMID: 20182719 BACKGROUND

Study Officials

• Dieter Hahnloser, Professor

  Centre Hospitalier Universitaire Vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

CH (7)