NCT00509054

Brief Summary

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
Last Updated

April 16, 2008

Status Verified

January 1, 2001

Enrollment Period

6.4 years

First QC Date

July 30, 2007

Last Update Submit

April 15, 2008

Conditions

Parastomal Hernia

Keywords

Parastomal hernia, wound infection, stoma care.

Outcome Measures

Primary Outcomes (1)

  • Wound infection,mesh infection, parastomal hernia.

    Within five years

Secondary Outcomes (1)

  • Fistula formation, stenosis,pain.

    Within five years

Interventions

Prophylactic meshPROCEDURE

A low weigth partly absorbable mesh in a subaly posistion

Also known as: Vypro mesh, Ethicon.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical need of an enterostoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirurgkliniken Sundsvalls sjukhus

Sundsvall, SE-85186, Sweden

Location

Related Publications (1)

  • Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.

    PMID: 15613293RESULT

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Leif A Israelsson, MD,PhD

    Umea University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

January 1, 2001

Primary Completion

June 1, 2007

Study Completion

July 1, 2007

Last Updated

April 16, 2008

Record last verified: 2001-01

Locations

SE(1)