NCT02233465

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

7 years

First QC Date

May 12, 2014

Last Update Submit

March 19, 2015

Conditions

Parastomal Hernia

Keywords

parastomalherniameshparastomal hernia-repair with mesh

Outcome Measures

Primary Outcomes (1)

  • Parastomal recurrence rate

    One year and three year

Secondary Outcomes (1)

  • Complications

    three months, one year and three year

Study Arms (2)

IPOM Mesh-repair parastomal hernia

EXPERIMENTAL

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

No mesh-repair

NO INTERVENTION

Patients not attending the study

Interventions

IPOM Mesh-repair parastomal herniaPROCEDURE

Safety study for mesh-repair of parastomal hernia

Also known as: Device: Parastomal hernia patch BARD
IPOM Mesh-repair parastomal hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parastomal hernia requiring surgery, over the age of 18

You may not qualify if:

  • Patient not accepting participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Pia Näsvall, MD

    Dep of Surgical and Perioperative Sciences, Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 12, 2014

First Posted

September 8, 2014

Study Start

January 1, 2008

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03