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

Primary Purpose

Parastomal Hernia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colostomy with mesh implantation
Simple colostomy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parastomal Hernia focused on measuring mesh, hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Besancon
  • CHU de Bordeaux
  • CHRU de Clermont Ferrand
  • APHP - Hôpital Beaujon
  • Hôpital Albert Michallon, CHU de Grenoble
  • APHP - Centre Hospitalier Universitaire de Bicêtre
  • CHRU de Lille - Hôpital Claude Huriez
  • Centre de Lutte Contre le Cancer - Centre Oscar Lambret
  • CHU de Lyon
  • Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
  • APHM - Hôpital La Timone Adultes
  • Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
  • CHU de Nantes
  • Centre Hospitalier Universitaire de Nîmes
  • APHP - Hôpital Saint-Antoine
  • APHP - Groupe Hospitalier Pitié-Salpetrière
  • APHP - Hôpital Lariboisière
  • Hôpital Pontchailou
  • CHU de Rouen
  • Centre Régional de Lutte contre le Cancer Centre Paul Strauss
  • CHU de Toulouse
  • CH de Vichy - Jacques Larin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesh

No mesh

Arm Description

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.

The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.

Outcomes

Primary Outcome Measures

Presence/absence of a peristomal hernia
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
The presence of absence of a hernia is detected by clinical exam.
Days of hospitalisation
The number of days spent in the hospital after the surgical intervention.
Operating time (minutes)
Estimation of blood loss during the operation (ml)
Was stomal repair necessary for the patient? yes/no
Was relocation of the colostomy required? yes/no
Presence/absence of complications
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.
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
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Pain medication consumption
Number of colostomy leaks per day
Number of colostomy sac changes per day
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Exposition of the prothesis (mesh): yes/no
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Presence/absence of peri-operative complications
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Presence/absence of complications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Pain medication consumption
Pain medication consumption
Pain medication consumption
Pain medication consumption
Pain medication consumption
Pain medication consumption
Pain medication consumption
Pain medication consumption
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy leaks per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Number of colostomy sac changes per day
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Exposition of the prothesis (mesh): yes/no
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Presence/absence of a complication potentially linked to the presence of a mesh?
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Ablation of the mesh: yes/no
Evaluation of colostomy healing by the clinician
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
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
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
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
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
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
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
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
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
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)
Presence/absence of postoperative fever > 37.2°C

Full Information

First Posted
June 22, 2011
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01380860
Brief Title
Primary Prevention of Peristomial Hernias Via Parietal Prostheses
Acronym
GRECCAR 07
Official Title
Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 20, 2016 (Actual)
Study Completion Date
October 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia
Keywords
mesh, hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesh
Arm Type
Experimental
Arm Description
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.
Arm Title
No mesh
Arm Type
Active Comparator
Arm Description
The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.
Intervention Type
Procedure
Intervention Name(s)
Colostomy with mesh implantation
Intervention Description
Colostomy with mesh implantation
Intervention Type
Procedure
Intervention Name(s)
Simple colostomy
Intervention Description
Colostomy with no mesh implantation.
Primary Outcome Measure Information:
Title
Presence/absence of a peristomal hernia
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
12 months
Title
Days of hospitalisation
Description
The number of days spent in the hospital after the surgical intervention.
Time Frame
1 month
Title
Operating time (minutes)
Time Frame
Day 1
Title
Estimation of blood loss during the operation (ml)
Time Frame
Day 1
Title
Was stomal repair necessary for the patient? yes/no
Time Frame
24 months
Title
Was relocation of the colostomy required? yes/no
Time Frame
24 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
24 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
24 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
24 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
24 months
Title
Pain medication consumption
Time Frame
24 months
Title
Number of colostomy leaks per day
Time Frame
24 months
Title
Number of colostomy sac changes per day
Time Frame
24 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
24 months
Title
Questionnaire Stoma-QOL
Description
Validated assessment of quality of life.
Time Frame
24 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
24 months
Title
Questionnaire Stoma-QOL
Description
Validated assessment of quality of life.
Time Frame
12 months
Title
Questionnaire Stoma-QOL
Description
Validated assessment of quality of life.
Time Frame
1 month
Title
Presence/absence of peri-operative complications
Time Frame
Day 1
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
Day 1
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
1 month
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
3 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
6 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
9 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
12 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
15 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
18 months
Title
Pain around the colostomy
Description
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time Frame
21 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
Day 1
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
1 month
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
3 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
6 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
9 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
12 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
15 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
18 months
Title
Abdominal pain
Description
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time Frame
21 months
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
1 month
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
3 months
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
6 months
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
9 months
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
15 months
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
18 months
Title
Presence/absence of peristomal hernia
Description
The presence of absence of a hernia is detected by clinical exam.
Time Frame
21 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
1 month
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
3 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
6 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
9 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
12 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
15 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
18 months
Title
Presence/absence of complications
Description
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time Frame
21 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
Day 1
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
1 month
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
3 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
6 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
9 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
12 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
15 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
18 months
Title
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Description
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.
Time Frame
21 months
Title
Pain medication consumption
Time Frame
Day 1
Title
Pain medication consumption
Time Frame
1 month
Title
Pain medication consumption
Time Frame
3 months
Title
Pain medication consumption
Time Frame
6 months
Title
Pain medication consumption
Time Frame
9 months
Title
Pain medication consumption
Time Frame
12 months
Title
Pain medication consumption
Time Frame
15 months
Title
Pain medication consumption
Time Frame
18 months
Title
Pain medication consumption
Time Frame
21 months
Title
Number of colostomy leaks per day
Time Frame
Day 1
Title
Number of colostomy leaks per day
Time Frame
1 month
Title
Number of colostomy leaks per day
Time Frame
3 months
Title
Number of colostomy leaks per day
Time Frame
6 months
Title
Number of colostomy leaks per day
Time Frame
9 months
Title
Number of colostomy leaks per day
Time Frame
12 months
Title
Number of colostomy leaks per day
Time Frame
18 months
Title
Number of colostomy leaks per day
Time Frame
15 months
Title
Number of colostomy leaks per day
Time Frame
21 months
Title
Number of colostomy sac changes per day
Time Frame
Day 1
Title
Number of colostomy sac changes per day
Time Frame
1 month
Title
Number of colostomy sac changes per day
Time Frame
3 months
Title
Number of colostomy sac changes per day
Time Frame
6 months
Title
Number of colostomy sac changes per day
Time Frame
9 months
Title
Number of colostomy sac changes per day
Time Frame
12 months
Title
Number of colostomy sac changes per day
Time Frame
15 months
Title
Number of colostomy sac changes per day
Time Frame
18 months
Title
Number of colostomy sac changes per day
Time Frame
21 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
Day 1
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
1 month
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
3 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
6 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
9 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
12 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
15 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
18 months
Title
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time Frame
21 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
1 month
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
3 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
6 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
9 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
12 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
15 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
18 months
Title
Exposition of the prothesis (mesh): yes/no
Time Frame
21 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
1 month
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
3 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
6 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
9 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
12 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
15 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
18 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
21 months
Title
Presence/absence of a complication potentially linked to the presence of a mesh?
Time Frame
24 months
Title
Ablation of the mesh: yes/no
Time Frame
1 month
Title
Ablation of the mesh: yes/no
Time Frame
3 months
Title
Ablation of the mesh: yes/no
Time Frame
6 months
Title
Ablation of the mesh: yes/no
Time Frame
9 months
Title
Ablation of the mesh: yes/no
Time Frame
12 months
Title
Ablation of the mesh: yes/no
Time Frame
15 months
Title
Ablation of the mesh: yes/no
Time Frame
18 months
Title
Ablation of the mesh: yes/no
Time Frame
21 months
Title
Ablation of the mesh: yes/no
Time Frame
24 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
Day 1
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
1 month
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
3 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
6 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
9 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
12 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
15 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
18 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
21 months
Title
Evaluation of colostomy healing by the clinician
Description
The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
Time Frame
24 months
Title
Duration of postoperative fever (hours)
Time Frame
10 days
Title
Presence/absence of postoperative fever > 37.2°C
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Prudhomme, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
CHRU de Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
APHP - Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Albert Michallon, CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
APHP - Centre Hospitalier Universitaire de Bicêtre
City
Le Kremlin Bicêtre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU de Lille - Hôpital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHU de Lyon
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
APHM - Hôpital La Timone Adultes
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
APHP - Hôpital Saint-Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
APHP - Groupe Hospitalier Pitié-Salpetrière
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
APHP - Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Pontchailou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Régional de Lutte contre le Cancer Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Name
CH de Vichy - Jacques Larin
City
Vichy
ZIP/Postal Code
03207
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33201089
Citation
Prudhomme M, Rullier E, Lakkis Z, Cotte E, Panis Y, Meunier B, Rouanet P, Tuech JJ, Jafari M, Portier G, Dubois A, Sielezneff I, Parc Y, Faucheron JL, Meurette G, Lelong B, Piessen G, Karoui M, Fabbro-Peray P, Demattei C, Bertrand MM; GRECCAR research group. End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial. Ann Surg. 2021 Dec 1;274(6):928-934. doi: 10.1097/SLA.0000000000004371.
Results Reference
derived
PubMed Identifier
27130912
Citation
Prudhomme M, Alline M, Chauvat J, Fabbro-Perray P, Ripoche J, Bertrand MM; French Research Group of Rectal Cancer Surgery (GRECCAR). Primary prevention of peristomial hernias via parietal prostheses: A randomized, multicentric study (GRECCAR 7 trial). Dig Liver Dis. 2016 Jul;48(7):812-6. doi: 10.1016/j.dld.2016.03.020. Epub 2016 Apr 5.
Results Reference
derived

Learn more about this trial

Primary Prevention of Peristomial Hernias Via Parietal Prostheses

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