Treating Parastomal Hernia With a Mesh

Parastomal Hernia Clinical Trial

Official title:

Mesh-repair With Inraperitoneal On-lay Mesh (IPOM) for Parastomal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233465
• Other study ID #: 09-021M
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 12, 2014
• Last updated: March 19, 2015
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Norrbottens Lans Landsting
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Parastomal herniation is difficult to treat. Several different treatment has been tested but still none has revealed to be superior. The use of a mesh has been shown to be a promising way of treating. In this study the investigators will evaluate safety and hernia recurrence rate with a mesh tailored to treat parastomal hernias "Parastomal hernia mesh BARD" in patients with parastomal hernia requiring surgery.

Description:

Parastomal hernia is a common complication in patients with a stoma and may cause the patient difficulties with stomal dressing and leakage of stomal content, as well as pain and risk for incarceration. The exact hernia incidence is not known, it depends on the definition of whether a bulge is considered a hernia or not, as well as the duration of follow-up. The reported incidence ranges between 0 and 52%. The majority of parastomal hernias develop within a few years after the index operation, but can appear as late as 20 years after surgery.

There is no superior treatment for an existing parastomal hernia. Several methods have been tested and used such as stoma relocation, sutures to narrow the opening in the fascia and abdominal wall and fixation and closure of the lateral space but none has proven to prevent from recurrence of herniation. Mesh repair has been shown to give a lower recurrence rate 0-33%. No technical factor, such as site of stoma formation (through or lateral to rectus abdominis muscle), related to the construction of the stoma was proven to prevent hernia formation.

To find a way to prevent the occurrence of parastomal hernia is an important issue. Today there are reports proposing a mesh in sublay position at the index operation would prevent hernia formation. Although the results are promising these studies are small and they do not meet the issue late complications according to the mesh implant.

The use of intraperitoneal on-lay mesh (IPOM) is widely used to treat incisional hernia. A new mesh (Parastomal hernia mesh BARD) has been tailored to treat parastomal hernia. To evaluate safety and hernia recurrence rate using the BARD-mesh for treating parastomal hernia a prospective multicentre non-randomised study is performed. The aim is to include 50 patients in the study.

Patients with parastomal hernia requiring surgery due to leakage, problems with stoma dressing, bulging, incarceration and other problems related to the hernia will be offered enrollment in the study after informed consent. The preoperative examination include clinical examination, three dimensional ultrasonography (3D) and or computed tomography (CT) of the abdomen.

Surgery at the four hospitals will be performed by experienced colorectal surgeons with a special interest in parastomal hernias. Postoperatively the patients will be allowed to mobilize according to each hospital postoperative routines. Follow-up visits at one month, one year and three year are scheduled. Early complications like infections, ileus, myocardial infarction, pneumonia, urinary infection and thrombosis are evaluated at one-month follow-up by clinical examination. At one and three year follow-up late complications and possible recurrence of parastomal hernias will be searched for. CT will be performed one year postoperatively. At the three year follow-up CT and or 3D will be performed.

Important outcome measures are complications and recurrence of parastomal hernia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parastomal hernia requiring surgery, over the age of 18

Exclusion Criteria:

• Patient not accepting participation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Procedure:
• IPOM Mesh-repair parastomal hernia
Safety study for mesh-repair of parastomal hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norrbottens Lans Landsting

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parastomal recurrence rate		One year and three year	No
Secondary	Complications		three months, one year and three year	Yes