Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Primary Prevention of Peristomial Hernias Via Parietal Prostheses (GRECCAR 07)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01380860
First received: June 22, 2011
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

Condition Intervention
Parastomal Hernia
Procedure: Colostomy with mesh implantation
Procedure: Simple colostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of a peristomal hernia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The occurrence of peristomal hernias is determined in both groups every three months up until 24 months. The presence of absence of a hernia is detected by clinical exam, and at 24 months by an additional radiology exam. The primary outcome concerns rates at 24 months, primo-events only.


Secondary Outcome Measures:
  • Presence/absence of peristomal hernia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Days of hospitalisation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The number of days spent in the hospital after the surgical intervention.

  • Operating time (minutes) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Estimation of blood loss during the operation (ml) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Was stomal repair necessary for the patient? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Was relocation of the colostomy required? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Pain around the colostomy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Abdominal pain [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Pain medication consumption [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Number of colostomy leaks per day [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Questionnaire Stoma-QOL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Validated assessment of quality of life.

  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Questionnaire Stoma-QOL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Validated assessment of quality of life.

  • Questionnaire Stoma-QOL [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Validated assessment of quality of life.

  • Presence/absence of peri-operative complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Pain around the colostomy [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Pain around the colostomy [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of pain around the stomy site.

  • Abdominal pain [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Abdominal pain [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    A visual analog scale is used to assess the patient's perception of abdominal pain.

  • Presence/absence of peristomal hernia [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of peristomal hernia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of peristomal hernia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of peristomal hernia [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of peristomal hernia [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of peristomal hernia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of peristomal hernia [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    The presence of absence of a hernia is detected by clinical exam.

  • Presence/absence of complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Presence/absence of complications [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 21 months ] [ Designated as safety issue: No ]
    A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.

  • Pain medication consumption [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Pain medication consumption [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  • Number of colostomy leaks per day [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Number of colostomy leaks per day [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of colostomy sac changes per day [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Exposition of the prothesis (mesh): yes/no [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  • Ablation of the mesh: yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluation of colostomy healing by the clinician [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Evaluation of colostomy healing by the clinician [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.

  • Duration of postoperative fever (hours) [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Presence/absence of postoperative fever > 37.2°C [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesh
The patients allocated to this arm of the study will have mesh (Covidien France: mono filament polyester bidimensional knit) implanted in association with their colostomy.
Procedure: Colostomy with mesh implantation
Colostomy with mesh implantation
Active Comparator: No mesh
The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.
Procedure: Simple colostomy
Colostomy with no mesh implantation.

Detailed Description:
Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has given informed consent
  • The patient must be affiliated with a health insurance programme
  • The patient must be available for 24 months of follow-up
  • The patient requires a colostomy (primo-event, ie first colostomies only)

Exclusion Criteria:

  • The patient is currently participating in another interventional study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under guardianship
  • The patient refuses to sign the consent
  • It is impossible to communicate information to the patient (does not read French)
  • The patient is pregnant
  • The patient is breastfeeding
  • There is a contra-indication for any treatment used in this study
  • The subject has already had a colostomy
  • The subject has peritonitis
  • The subject needs a colostomy for infectious reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380860

Locations
France
CHRU de Besancon
Besancon, France, 25030
CHU de Bordeaux
Bordeaux, France, 33075
CHRU de Clermont Ferrand
Clermont Ferrand, France, 63058
APHP - Hôpital Beaujon
Clichy, France, 92110
Hôpital Albert Michallon, CHU de Grenoble
Grenoble, France, 38043
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin Bicêtre Cedex, France, 94275
CHRU de Lille - Hôpital Claude Huriez
Lille Cedex, France, 59037
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille, France, 59020
CHU de Lyon
Lyon, France, 69317
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
Marseille, France, 13009
APHM - Hôpital La Timone Adultes
Marseille, France, 13385
Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
Montpellier, France, 34298
CHU de Nantes
Nantes, France, 44093
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
APHP - Hôpital Saint-Antoine
Paris Cedex 12, France, 75571
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris Cedex 13, France, 75651
APHP - Hôpital Lariboisière
Paris, France, 75010
Hôpital Pontchailou
Rennes, France, 35033
CHU de Rouen
Rouen, France, 76038
Centre Régional de Lutte contre le Cancer Centre Paul Strauss
Strasbourg, France, 67065
CHU de Toulouse
Toulouse, France
CH de Vichy - Jacques Larin
Vichy, France, 03207
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Michel Prudhomme, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01380860     History of Changes
Other Study ID Numbers: PHRC-N/2011/MP-01  2011-A01572-39 
Study First Received: June 22, 2011
Last Updated: October 24, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
mesh
hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 07, 2016