Primary Prevention of Peristomial Hernias Via Parietal Prostheses

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

• Presence/absence of peristomal hernia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Days of hospitalisation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  The number of days spent in the hospital after the surgical intervention.
  
  
• Operating time (minutes) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  
• Estimation of blood loss during the operation (ml) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  
• Was stomal repair necessary for the patient? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  
• Was relocation of the colostomy required? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Pain around the colostomy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Abdominal pain [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Pain medication consumption [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  
• Number of colostomy leaks per day [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  
• Questionnaire Stoma-QOL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Validated assessment of quality of life.
  
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  
• Questionnaire Stoma-QOL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Validated assessment of quality of life.
  
  
• Questionnaire Stoma-QOL [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Validated assessment of quality of life.
  
  
• Presence/absence of peri-operative complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  
• Pain around the colostomy [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Pain around the colostomy [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of pain around the stomy site.
  
  
• Abdominal pain [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Abdominal pain [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  A visual analog scale is used to assess the patient's perception of abdominal pain.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of peristomal hernia [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  The presence of absence of a hernia is detected by clinical exam.
  
  
• Presence/absence of complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Presence/absence of complications [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Patient difficulty for fitting his/her colostomy with the appropriate sac. [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.
  
  
• Pain medication consumption [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  
• Pain medication consumption [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  
• Number of colostomy leaks per day [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  
• Number of colostomy leaks per day [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• Number of colostomy sac changes per day [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  
• Exposition of the prothesis (mesh): yes/no [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  
• Presence/absence of a complication potentially linked to the presence of a mesh? [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  
• Ablation of the mesh: yes/no [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  
• Evaluation of colostomy healing by the clinician [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Evaluation of colostomy healing by the clinician [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.
  
  
• Duration of postoperative fever (hours) [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  
• Presence/absence of postoperative fever > 37.2°C [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  

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.