Primary Prevention of Peristomial Hernias Via Parietal Prostheses

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01380860
First received: June 22, 2011
Last updated: March 4, 2014
Last verified: March 2014
  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 ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380860

Contacts
Contact: Michel Prudhomme, MD PhD +33.(0)4.66.68.31.43 michel.prudhomme@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.15 carey.suehs@chu-nimes.fr

Locations
France
CHRU de Besancon Recruiting
Besancon, France, 25030
Sub-Investigator: Georges Mantion, MD PhD         
CHU de Bordeaux Recruiting
Bordeaux, France, 33075
Sub-Investigator: Eric Rullier, MD PhD         
Sub-Investigator: Christophe Laurent, MD PhD         
CHRU de Clermont Ferrand Recruiting
Clermont Ferrand, France, 63058
Sub-Investigator: Denis Pezet, MD PhD         
Sub-Investigator: Emmanuel Buc, MD         
Sub-Investigator: Renaud Flamein, MD         
APHP - Hôpital Beaujon Recruiting
Clichy, France, 92110
Sub-Investigator: Yves Panis, MD, PhD         
Hôpital Albert Michallon, CHU de Grenoble Recruiting
Grenoble, France, 38043
Sub-Investigator: Jean-Luc Faucheron, MD PhD         
APHP - Centre Hospitalier Universitaire de Bicêtre Recruiting
Le Kremlin Bicêtre Cedex, France, 94275
Sub-Investigator: Stéphane Benoist, MD, PhD         
CHU de Lyon Recruiting
Lyon, France, 69317
Sub-Investigator: Eddy Cotte, MD         
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Sub-Investigator: Bernard Lelong, MD         
APHM - Hôpital La Timone Adultes Recruiting
Marseille, France, 13385
Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque Recruiting
Montpellier, France, 34298
Sub-Investigator: Philippe Rouanet, MD PhD         
CHU de Nantes Recruiting
Nantes, France, 44093
Sub-Investigator: Guillaume Meurette, MD         
Sub-Investigator: Paul Antoine Lehur, MD PhD         
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes, France, 30029
Principal Investigator: Michel Prudhomme, MD PhD         
Sub-Investigator: Sylvain Laporte, MD         
Sub-Investigator: Marie Christine Lemoine, MD         
APHP - Hôpital Lariboisière Recruiting
Paris, France, 75010
APHP - Hôpital Saint-Antoine Recruiting
Paris Cedex 12, France, 75571
Sub-Investigator: Yann Parc, MD, PhD         
APHP - Groupe Hospitalier Pitié-Salpetrière Recruiting
Paris Cedex 13, France, 75651
Sub-Investigator: Medhi Karoui, MD, PhD         
Hôpital Pontchailou Recruiting
Rennes, France, 35033
Sub-Investigator: Bernard Meunier, MD PhD         
CHU de Rouen Recruiting
Rouen, France, 76038
Sub-Investigator: Francis Michot, MD PhD         
Sub-Investigator: Jean Jacques Tuech, MD         
Centre Régional de Lutte contre le Cancer Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Sub-Investigator: Jean-Claude Ollier, MD PhD         
CHU de Toulouse Recruiting
Toulouse, France
Sub-Investigator: Guillaume Portier, MD PhD         
CH de Vichy - Jacques Larin Recruiting
Vichy, France, 03207
Sub-Investigator: Anne Dubois, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Michel Prudhomme, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

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: March 4, 2014
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 April 17, 2014