Parastomal Hernia
Conditions
Keywords
mesh, hernia
Brief summary
The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.
Detailed description
Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy port. Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.
Interventions
PROCEDUREColostomy with mesh implantation
Colostomy with mesh implantation
PROCEDURESimple colostomy
Colostomy with no mesh implantation.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of a peristomal hernia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Was stomal repair necessary for the patient? yes/no | 24 months | — |
| Was relocation of the colostomy required? yes/no | 24 months | — |
| Presence/absence of peristomal hernia | 12 months | The presence of absence of a hernia is detected by clinical exam. |
| Days of hospitalisation | 1 month | The number of days spent in the hospital after the surgical intervention. |
| Operating time (minutes) | Day 1 | — |
| Presence/absence of complications | 24 months | 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. | 24 months | 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 | 24 months | A visual analog scale is used to assess the patient's perception of pain around the stomy site. |
| Abdominal pain | 24 months | A visual analog scale is used to assess the patient's perception of abdominal pain. |
| Pain medication consumption | 24 months | — |
| Estimation of blood loss during the operation (ml) | Day 1 | — |
| 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 | 24 months | Validated assessment of quality of life. |
| Exposition of the prothesis (mesh): yes/no | 24 months | — |
| Presence/absence of peri-operative complications | Day 1 | — |
| Presence/absence of a complication potentially linked to the presence of a mesh? | 1 month | — |
| Ablation of the mesh: yes/no | 1 month | — |
| Evaluation of colostomy healing by the clinician | Day 1 | 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) | 10 days | — |
| Presence/absence of postoperative fever > 37.2°C | Day 1 | — |
| Number of colostomy leaks per day | 24 months | — |
Countries
France
Outcome results
None listed