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Treating Parastomal Hernia With a Mesh

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ClinicalTrials.gov Identifier: NCT02233465
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pia Nasvall, Norrbottens Lans Landsting

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.

Condition or disease Intervention/treatment Phase
Parastomal Hernia Procedure: IPOM Mesh-repair parastomal hernia Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesh-repair With Inraperitoneal On-lay Mesh (IPOM) for Parastomal Hernia
Study Start Date : January 2008
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: 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.
Procedure: IPOM Mesh-repair parastomal hernia
Safety study for mesh-repair of parastomal hernia
Other Name: Device: Parastomal hernia patch BARD

No Intervention: No mesh-repair
Patients not attending the study



Primary Outcome Measures :
  1. Parastomal recurrence rate [ Time Frame: One year and three year ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: three months, one year and three year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parastomal hernia requiring surgery, over the age of 18

Exclusion Criteria:

  • Patient not accepting participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233465


Sponsors and Collaborators
Norrbottens Lans Landsting
Investigators
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Principal Investigator: Pia Näsvall, MD Dep of Surgical and Perioperative Sciences, Umeå University
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Responsible Party: Pia Nasvall, MD, Norrbottens Lans Landsting
ClinicalTrials.gov Identifier: NCT02233465    
Other Study ID Numbers: 09-021M
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Pia Nasvall, Norrbottens Lans Landsting:
parastomal
hernia
mesh
parastomal hernia-repair with mesh
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical