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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Colostomy with mesh implantation
Colostomy with no mesh implantation.
CHRU de Besancon
Besançon, France
CHU de Bordeaux
Bordeaux, France
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.
Time frame: 24 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 12 months
Days of hospitalisation
The number of days spent in the hospital after the surgical intervention.
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
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 24 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHRU de Clermont Ferrand
Clermont-Ferrand, France
APHP - Hôpital Beaujon
Clichy, France
Hôpital Albert Michallon, CHU de Grenoble
Grenoble, France
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, France
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille, France
CHRU de Lille - Hôpital Claude Huriez
Lille, France
CHU de Lyon
Lyon, France
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
Marseille, France
...and 12 more locations
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
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 24 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of 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
Validated assessment of quality of life.
Time frame: 24 months
Exposition of the prothesis (mesh): yes/no
Time frame: 24 months
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Time frame: 12 months
Questionnaire Stoma-QOL
Validated assessment of quality of life.
Time frame: 1 month
Presence/absence of peri-operative complications
Time frame: Day 1
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: Day 1
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 1 month
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 3 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 6 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 9 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 12 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 15 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 18 months
Pain around the colostomy
A visual analog scale is used to assess the patient's perception of pain around the stomy site.
Time frame: 21 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: Day 1
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 1 month
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 3 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 6 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 9 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 12 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 15 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 18 months
Abdominal pain
A visual analog scale is used to assess the patient's perception of abdominal pain.
Time frame: 21 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 1 month
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 3 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 6 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 9 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 15 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 18 months
Presence/absence of peristomal hernia
The presence of absence of a hernia is detected by clinical exam.
Time frame: 21 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 1 month
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 3 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 6 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 9 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 12 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 15 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 18 months
Presence/absence of complications
Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21 months
Pain medication consumption
Time frame: Day 1
Pain medication consumption
Time frame: 1 month
Pain medication consumption
Time frame: 3 months
Pain medication consumption
Time frame: 6 months
Pain medication consumption
Time frame: 9 months
Pain medication consumption
Time frame: 12 months
Pain medication consumption
Time frame: 15 months
Pain medication consumption
Time frame: 18 months
Pain medication consumption
Time frame: 21 months
Number of colostomy leaks per day
Time frame: Day 1
Number of colostomy leaks per day
Time frame: 1 month
Number of colostomy leaks per day
Time frame: 3 months
Number of colostomy leaks per day
Time frame: 6 months
Number of colostomy leaks per day
Time frame: 9 months
Number of colostomy leaks per day
Time frame: 12 months
Number of colostomy leaks per day
Time frame: 18 months
Number of colostomy leaks per day
Time frame: 15 months
Number of colostomy leaks per day
Time frame: 21 months
Number of colostomy sac changes per day
Time frame: Day 1
Number of colostomy sac changes per day
Time frame: 1 month
Number of colostomy sac changes per day
Time frame: 3 months
Number of colostomy sac changes per day
Time frame: 6 months
Number of colostomy sac changes per day
Time frame: 9 months
Number of colostomy sac changes per day
Time frame: 12 months
Number of colostomy sac changes per day
Time frame: 15 months
Number of colostomy sac changes per day
Time frame: 18 months
Number of colostomy sac changes per day
Time frame: 21 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: Day 1
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 1 month
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 3 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 6 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 9 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 12 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 15 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 18 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
Time frame: 21 months
Exposition of the prothesis (mesh): yes/no
Time frame: 1 month
Exposition of the prothesis (mesh): yes/no
Time frame: 3 months
Exposition of the prothesis (mesh): yes/no
Time frame: 6 months
Exposition of the prothesis (mesh): yes/no
Time frame: 9 months
Exposition of the prothesis (mesh): yes/no
Time frame: 12 months
Exposition of the prothesis (mesh): yes/no
Time frame: 15 months
Exposition of the prothesis (mesh): yes/no
Time frame: 18 months
Exposition of the prothesis (mesh): yes/no
Time frame: 21 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 1 month
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 3 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 6 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 9 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 12 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 15 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 18 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 21 months
Presence/absence of a complication potentially linked to the presence of a mesh?
Time frame: 24 months
Ablation of the mesh: yes/no
Time frame: 1 month
Ablation of the mesh: yes/no
Time frame: 3 months
Ablation of the mesh: yes/no
Time frame: 6 months
Ablation of the mesh: yes/no
Time frame: 9 months
Ablation of the mesh: yes/no
Time frame: 12 months
Ablation of the mesh: yes/no
Time frame: 15 months
Ablation of the mesh: yes/no
Time frame: 18 months
Ablation of the mesh: yes/no
Time frame: 21 months
Ablation of the mesh: yes/no
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Duration of postoperative fever (hours)
Time frame: 10 days
Presence/absence of postoperative fever > 37.2°C
Time frame: Day 1