Primary Prevention of Peristomial Hernias Via Parietal Prostheses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study

Conditions
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Parastomal Hernia

Intervention / Treatment
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* Procedure: Colostomy with mesh implantation
* Procedure: Simple colostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh<br>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<br>* Colostomy with mesh implantation<br>|
| Active Comparator: No mesh<br>The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy. | Procedure: Simple colostomy<br>* Colostomy with no mesh implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 12 months | 
| Days of hospitalisation | The number of days spent in the hospital after the surgical intervention. | 1 month | 
| Operating time (minutes) |  | Day 1 | 
| Estimation of blood loss during the operation (ml) |  | Day 1 | 
| Was stomal repair necessary for the patient? yes/no |  | 24 months | 
| Was relocation of the colostomy required? yes/no |  | 24 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 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. | 24 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 24 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 24 months | 
| Pain medication consumption |  | 24 months | 
| Number of colostomy leaks per day |  | 24 months | 
| Number of colostomy sac changes per day |  | 24 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 24 months | 
| Questionnaire Stoma-QOL | Validated assessment of quality of life. | 24 months | 
| Exposition of the prothesis (mesh): yes/no |  | 24 months | 
| Questionnaire Stoma-QOL | Validated assessment of quality of life. | 12 months | 
| Questionnaire Stoma-QOL | Validated assessment of quality of life. | 1 month | 
| Presence/absence of peri-operative complications |  | Day 1 | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | Day 1 | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 1 month | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 3 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 6 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 9 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 12 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 15 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 18 months | 
| Pain around the colostomy | A visual analog scale is used to assess the patient's perception of pain around the stomy site. | 21 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | Day 1 | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 1 month | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 3 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 6 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 9 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 12 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 15 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 18 months | 
| Abdominal pain | A visual analog scale is used to assess the patient's perception of abdominal pain. | 21 months | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 1 month | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 3 months | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 6 months | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 9 months | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 15 months | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 18 months | 
| Presence/absence of peristomal hernia | The presence of absence of a hernia is detected by clinical exam. | 21 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 1 month | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 3 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 6 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 9 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 12 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 15 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 18 months | 
| Presence/absence of complications | Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 21 months | 
| Pain medication consumption |  | Day 1 | 
| Pain medication consumption |  | 1 month | 
| Pain medication consumption |  | 3 months | 
| Pain medication consumption |  | 6 months | 
| Pain medication consumption |  | 9 months | 
| Pain medication consumption |  | 12 months | 
| Pain medication consumption |  | 15 months | 
| Pain medication consumption |  | 18 months | 
| Pain medication consumption |  | 21 months | 
| Number of colostomy leaks per day |  | Day 1 | 
| Number of colostomy leaks per day |  | 1 month | 
| Number of colostomy leaks per day |  | 3 months | 
| Number of colostomy leaks per day |  | 6 months | 
| Number of colostomy leaks per day |  | 9 months | 
| Number of colostomy leaks per day |  | 12 months | 
| Number of colostomy leaks per day |  | 18 months | 
| Number of colostomy leaks per day |  | 15 months | 
| Number of colostomy leaks per day |  | 21 months | 
| Number of colostomy sac changes per day |  | Day 1 | 
| Number of colostomy sac changes per day |  | 1 month | 
| Number of colostomy sac changes per day |  | 3 months | 
| Number of colostomy sac changes per day |  | 6 months | 
| Number of colostomy sac changes per day |  | 9 months | 
| Number of colostomy sac changes per day |  | 12 months | 
| Number of colostomy sac changes per day |  | 15 months | 
| Number of colostomy sac changes per day |  | 18 months | 
| Number of colostomy sac changes per day |  | 21 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | Day 1 | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 1 month | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 3 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 6 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 9 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 12 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 15 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 18 months | 
| Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no |  | 21 months | 
| Exposition of the prothesis (mesh): yes/no |  | 1 month | 
| Exposition of the prothesis (mesh): yes/no |  | 3 months | 
| Exposition of the prothesis (mesh): yes/no |  | 6 months | 
| Exposition of the prothesis (mesh): yes/no |  | 9 months | 
| Exposition of the prothesis (mesh): yes/no |  | 12 months | 
| Exposition of the prothesis (mesh): yes/no |  | 15 months | 
| Exposition of the prothesis (mesh): yes/no |  | 18 months | 
| Exposition of the prothesis (mesh): yes/no |  | 21 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 1 month | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 3 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 6 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 9 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 12 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 15 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 18 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 21 months | 
| Presence/absence of a complication potentially linked to the presence of a mesh? |  | 24 months | 
| Ablation of the mesh: yes/no |  | 1 month | 
| Ablation of the mesh: yes/no |  | 3 months | 
| Ablation of the mesh: yes/no |  | 6 months | 
| Ablation of the mesh: yes/no |  | 9 months | 
| Ablation of the mesh: yes/no |  | 12 months | 
| Ablation of the mesh: yes/no |  | 15 months | 
| Ablation of the mesh: yes/no |  | 18 months | 
| Ablation of the mesh: yes/no |  | 21 months | 
| Ablation of the mesh: yes/no |  | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months | 
| Duration of postoperative fever (hours) |  | 10 days | 
| Presence/absence of postoperative fever > 37.2°C |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesh, hernia