NCT00908661

Brief Summary

The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

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

November 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

May 25, 2009

Last Update Submit

March 23, 2017

Conditions

Parastomal Hernia

Keywords

Parastomal, hernia

Outcome Measures

Primary Outcomes (1)

  • If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done

    24 to 36 months after surgery

Secondary Outcomes (1)

  • Measuring the quality of life using the SF-36

    Preoperative and at the end of the study

Study Arms (2)

Prophylactic mesh

ACTIVE COMPARATOR

All patients will have a permanent ostomy and a randomisation with prophylactic mesh

Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

without prophylactic mesh

NO INTERVENTION

All patients will have a permanent ostomy and a randomisation without prophylactic mesh

Interventions

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose meshDEVICE

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Also known as: PROCEED mesh
Prophylactic mesh

Eligibility Criteria

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

You may qualify if:

  • Patients with permanent ostomy and 1 years of life expectancy
  • Signed informed consent

You may not qualify if:

  • Allergy to the compounds of the mesh
  • Rejection of the patient
  • Rejection of the surgeon
  • Field of emergency
  • Life expectancy \< 1 year
  • Prior meshes in the surgical site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Valldhebron Research Institute

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (3)

  • Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809.

    PMID: 19300232BACKGROUND

  • Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58.

    PMID: 19502871BACKGROUND

  • Lopez-Cano M, Lozoya-Trujillo R, Quiroga S, Sanchez JL, Vallribera F, Marti M, Jimenez LM, Armengol-Carrasco M, Espin E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11.

    PMID: 22782367DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2009

First Posted

May 27, 2009

Study Start

November 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 27, 2017

Record last verified: 2011-03

Locations

ES(1)