Parastomal HerniaGRECCAR 07NCT01380860
Primary Prevention of Peristomial Hernias Via Parietal Prostheses
A study testing Colostomy with mesh implantation and Simple colostomy in people with Parastomal Hernia, run by Centre Hospitalier Universitaire de Nīmes at 22 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Colostomy with mesh implantation and Simple colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 22 sitesFrance
- Study dates
- Nov 2012to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
CHRU de Besancon
Besançon, 25030
CHU de Bordeaux
Bordeaux, 33075
CHRU de Clermont Ferrand
Clermont-Ferrand, 63058
APHP - Hôpital Beaujon
Clichy, 92110
Hôpital Albert Michallon, CHU de Grenoble
Grenoble, 38043
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, 94275
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille, 59020
CHRU de Lille - Hôpital Claude Huriez
Lille, 59037
CHU de Lyon
Lyon, 69317
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
Marseille, 13009
APHM - Hôpital La Timone Adultes
Marseille, 13385
Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
Montpellier, 34298
CHU de Nantes
Nantes, 44093
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
APHP - Hôpital Lariboisière
Paris, 75010
APHP - Hôpital Saint-Antoine
Paris, 75571
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651
Hôpital Pontchailou
Rennes, 35033
CHU de Rouen
Rouen, 76038
Centre Régional de Lutte contre le Cancer Centre Paul Strauss
Strasbourg, 67065
CHU de Toulouse
Toulouse
CH de Vichy - Jacques Larin
Vichy, 03207
About this study
Official title: Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
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.
Read the 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.
- Conditions
- Parastomal Hernia
- Being tested
- Colostomy with mesh implantation, Simple colostomy
- Keywords
- mesh, hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colostomy with mesh implantationProcedure or surgery
Colostomy with mesh implantation
Simple colostomyProcedure or surgery
Colostomy with no mesh implantation.
| Study group | Role | What they receive |
|---|---|---|
| Mesh | Experimental | 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. Receives: Procedure: Colostomy with mesh implantation |
| No mesh | Active comparator | The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy. Receives: Procedure: Simple colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (135)
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 12 months
Days of hospitalisation
The number of days spent in the hospital after the surgical intervention.
Measured: 1 month
Operating time (minutes)
Measured: Day 1
Estimation of blood loss during the operation (ml)
Measured: Day 1
Was stomal repair necessary for the patient? yes/no
Measured: 24 months
Was relocation of the colostomy required? yes/no
Measured: 24 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 24 months
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.
Measured: 24 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 24 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 24 months
Pain medication consumption
Measured: 24 months
Number of colostomy leaks per day
Measured: 24 months
Number of colostomy sac changes per day
Measured: 24 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 24 months
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Measured: 24 months
Exposition of the prothesis (mesh): yes/no
Measured: 24 months
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Measured: 12 months
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Measured: 1 month
Presence/absence of peri-operative complications
Measured: Day 1
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: Day 1
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 1 month
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 3 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 6 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 9 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 12 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 15 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 18 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Measured: 21 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: Day 1
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 1 month
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 3 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 6 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 9 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 12 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 15 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 18 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Measured: 21 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 1 month
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 3 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 6 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 9 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 15 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 18 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Measured: 21 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 1 month
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 3 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 6 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 9 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 12 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 15 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 18 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Measured: 21 months
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.
Measured: Day 1
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 12 months
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.
Measured: 15 months
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.
Measured: 18 months
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.
Measured: 21 months
Pain medication consumption
Measured: Day 1
Pain medication consumption
Measured: 1 month
Pain medication consumption
Measured: 3 months
Pain medication consumption
Measured: 6 months
Pain medication consumption
Measured: 9 months
Pain medication consumption
Measured: 12 months
Pain medication consumption
Measured: 15 months
Pain medication consumption
Measured: 18 months
Pain medication consumption
Measured: 21 months
Number of colostomy leaks per day
Measured: Day 1
Number of colostomy leaks per day
Measured: 1 month
Number of colostomy leaks per day
Measured: 3 months
Number of colostomy leaks per day
Measured: 6 months
Number of colostomy leaks per day
Measured: 9 months
Number of colostomy leaks per day
Measured: 12 months
Number of colostomy leaks per day
Measured: 18 months
Number of colostomy leaks per day
Measured: 15 months
Number of colostomy leaks per day
Measured: 21 months
Number of colostomy sac changes per day
Measured: Day 1
Number of colostomy sac changes per day
Measured: 1 month
Number of colostomy sac changes per day
Measured: 3 months
Number of colostomy sac changes per day
Measured: 6 months
Number of colostomy sac changes per day
Measured: 9 months
Number of colostomy sac changes per day
Measured: 12 months
Number of colostomy sac changes per day
Measured: 15 months
Number of colostomy sac changes per day
Measured: 18 months
Number of colostomy sac changes per day
Measured: 21 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: Day 1
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 1 month
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 3 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 6 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 9 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 12 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 15 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 18 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Measured: 21 months
Exposition of the prothesis (mesh): yes/no
Measured: 1 month
Exposition of the prothesis (mesh): yes/no
Measured: 3 months
Exposition of the prothesis (mesh): yes/no
Measured: 6 months
Exposition of the prothesis (mesh): yes/no
Measured: 9 months
Exposition of the prothesis (mesh): yes/no
Measured: 12 months
Exposition of the prothesis (mesh): yes/no
Measured: 15 months
Exposition of the prothesis (mesh): yes/no
Measured: 18 months
Exposition of the prothesis (mesh): yes/no
Measured: 21 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 1 month
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 3 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 6 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 9 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 12 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 15 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 18 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 21 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Measured: 24 months
Ablation of the mesh: yes/no
Measured: 1 month
Ablation of the mesh: yes/no
Measured: 3 months
Ablation of the mesh: yes/no
Measured: 6 months
Ablation of the mesh: yes/no
Measured: 9 months
Ablation of the mesh: yes/no
Measured: 12 months
Ablation of the mesh: yes/no
Measured: 15 months
Ablation of the mesh: yes/no
Measured: 18 months
Ablation of the mesh: yes/no
Measured: 21 months
Ablation of the mesh: yes/no
Measured: 24 months
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.
Measured: Day 1
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 12 months
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.
Measured: 15 months
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.
Measured: 18 months
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.
Measured: 21 months
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.
Measured: 24 months
Duration of postoperative fever (hours)
Measured: 10 days
Presence/absence of postoperative fever > 37.2°C
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startNov 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Prudhomme, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380860
- Sponsor's protocol ID
- PHRC-N/2011/MP-01
- Other IDs
- 2011-A01572-39
- Acronym
- GRECCAR 07
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2011
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33201089Prudhomme 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.
PubMed 27130912
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
- ClinicalTrials.gov ID
- NCT01380860
- Acronym / sponsor ID
- GRECCAR 07 / PHRC-N/2011/MP-01
- Conditions
- Parastomal Hernia
- Keywords
- mesh, hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh | Experimental | Procedure: Colostomy with mesh implantationThe patients allocated to this arm of the study will have mesh (Covidien France: mono filament polyester bidimensional knit) implanted in association with their colostomy. |
| No mesh | Active comparator | Procedure: Simple colostomyThe patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colostomy with mesh implantationColostomy with mesh implantation | Procedure or surgery | Mesh |
| Simple colostomyColostomy with no mesh implantation. | Procedure or surgery | No mesh |
Primary outcome
Presence/absence of a peristomal hernia
Time frame: 24 months
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.
135 secondary outcomes
Presence/absence of peristomal hernia
Time frame: 12 months
Days of hospitalisation
Time frame: 1 month
Operating time (minutes)
Time frame: Day 1
Estimation of blood loss during the operation (ml)
Time frame: Day 1
Was stomal repair necessary for the patient? yes/no
Time frame: 24 months
Was relocation of the colostomy required? yes/no
Time frame: 24 months
Presence/absence of complications
Time frame: 24 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.
Time frame: 24 months
Pain around the colostomy
Time frame: 24 months
Abdominal pain
Time frame: 24 months
Pain medication consumption
Time frame: 24 months
Number of colostomy leaks per day
Time frame: 24 months
Number of colostomy sac changes per day
Time frame: 24 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 24 months
Questionnaire Stoma-QOL
Time frame: 24 months
Exposition of the prothesis (mesh): yes/no
Time frame: 24 months
Questionnaire Stoma-QOL
Time frame: 12 months
Questionnaire Stoma-QOL
Time frame: 1 month
Presence/absence of peri-operative complications
Time frame: Day 1
Pain around the colostomy
Time frame: Day 1
Pain around the colostomy
Time frame: 1 month
Pain around the colostomy
Time frame: 3 months
Pain around the colostomy
Time frame: 6 months
Pain around the colostomy
Time frame: 9 months
Pain around the colostomy
Time frame: 12 months
Pain around the colostomy
Time frame: 15 months
Pain around the colostomy
Time frame: 18 months
Pain around the colostomy
Time frame: 21 months
Abdominal pain
Time frame: Day 1
Abdominal pain
Time frame: 1 month
Abdominal pain
Time frame: 3 months
Abdominal pain
Time frame: 6 months
Abdominal pain
Time frame: 9 months
Abdominal pain
Time frame: 12 months
Abdominal pain
Time frame: 15 months
Abdominal pain
Time frame: 18 months
Abdominal pain
Time frame: 21 months
Presence/absence of peristomal hernia
Time frame: 1 month
Presence/absence of peristomal hernia
Time frame: 3 months
Presence/absence of peristomal hernia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 33201089Prudhomme 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.
- Derived from this study: PubMed 27130912Prudhomme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Prudhomme, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colostomy with mesh implantation and Simple colostomy in people with Parastomal Hernia, run by Centre Hospitalier Universitaire de Nīmes at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of a peristomal hernia (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.