NCT00496418

Brief Summary

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_3

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

July 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4.2 years

First QC Date

July 3, 2007

Last Update Submit

January 12, 2015

Conditions

Hernia

Keywords

colostomyparastomalperistomalherniameshsurgeryIndication for permanent end colostomy

Outcome Measures

Primary Outcomes (1)

  • Parastomal hernia

    at 3, 12, 24, 36 and 48 months

Secondary Outcomes (1)

  • Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy

    4 years

Study Arms (2)

Prophylactic stoma mesh

EXPERIMENTAL

Mesh

Device: Mesh in permanent colostomy

No mesh prophylaxis

ACTIVE COMPARATOR

No mesh

Device: Mesh in permanent colostomy

Interventions

Mesh in permanent colostomyDEVICE
No mesh prophylaxisProphylactic stoma mesh

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Condition with indication for establishing a permanent end-colostomy.

You may not qualify if:

  • Age under 18
  • ASA score above 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF

Oslo, NO-0027, Norway

Location

Related Publications (1)

  • Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available.

    PMID: 32222841DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Lambrecht, MD

    Rikshospitalet-Radiumhospitalet HF, Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 4, 2007

Study Start

July 1, 2007

Primary Completion

September 1, 2011

Study Completion

November 1, 2014

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

NO(1)