Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient must be affiliated with a health insurance programme

Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)

Patient received colostomy 5 years ago

Disqualifiers

The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study

The subject signals opposition to participating in the study

The patient is under safeguard of justice or state guardianship

The patient is pregnant or breastfeeding

Trial population

The study population consists of patients included in the GRECCAR 07 cohort.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

134 Participants
are grouped into 2 trial groups
Group A: with mesh
Group B: no mesh

Trial outcomes

Primary outcomes

1

Rate of parastomal hernia between groups

Percentage patients with parastomal hernia taken from patient medical records

Time frame
5 years after colostomy formation
2

Date of parastomal hernia

Date of parastomal hernia taken from patient records

Time frame
5 years after colostomy formation

Secondary outcomes

1

Protrusion around the stoma

Yes/no

Time frame
5 years after colostomy formation
2

Patient reported pain

Yes/no

Time frame
5 years after colostomy formation
3

Occlusion

Yes/no

Time frame
5 years after colostomy formation
4

Incarceration

Yes/no

Time frame
5 years after colostomy formation

Other outcomes

Sponsors and contacts

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