Treating Parastomal Hernia With a Mesh

NCT ID: NCT02233465

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-01-31

Brief 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.

Detailed 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.

Conditions

Parastomal Hernia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPOM Mesh-repair parastomal hernia

Mesh-repair of para-stomal hernia. Patients with para-stomal hernia requiring surgery are offererd enrollment in the study. Preoperatively a CT-scan of the abdomen and or a 3D ultrasonography of the stoma is performed. All patients in the stydy are operated with IPOM-mesh designed for treatment of parastomal hernia.

Group Type: EXPERIMENTAL

IPOM Mesh-repair parastomal hernia

Intervention Type: PROCEDURE

Safety study for mesh-repair of parastomal hernia

No mesh-repair

Patients not attending the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IPOM Mesh-repair parastomal hernia

Safety study for mesh-repair of parastomal hernia

Intervention Type: PROCEDURE

Other Intervention Names

Device: Parastomal hernia patch BARD

Eligibility Criteria

Inclusion Criteria

• Parastomal hernia requiring surgery, over the age of 18

Exclusion Criteria

• Patient not accepting participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norrbottens Lans Landsting

OTHER

Sponsor Role: lead

Responsible Party

Pia Nasvall

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Näsvall, MD

Role: PRINCIPAL_INVESTIGATOR

Dep of Surgical and Perioperative Sciences, Umeå University

Other Identifiers

09-021M

Identifier Type: -

Identifier Source: org_study_id