An interventional study of Adhesix® monofilament polypropylene mesh (Bard Davol) in Incisional Hernia, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-11-23.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention
Rationale:
Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a parastomal herniation is high, with a reported incidence of 4-48%. Also, the former stoma site is at increased risk for the development of an incisional hernia. A clinical incisional hernia rate of 30% is reported after stoma reversal. Herniation can cause pain, deformity and possibly incarceration, which results in a significant impact on the quality of life of the patient.
The hypothesis of this study is that the use of a prophylactic mesh at the time of stoma formation leads to a lower incidence of incisional hernias after stoma reversal, an improved quality of life and therefore a possible cost reduction in healthcare.
Objective:
To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh placement compared to no mesh placement. In addition, we aim to assess the effect of preventive mesh placement on the quality of life and the effect on healthcare cost reduction by avoiding re-intervention.
Study design:
A multicentre double blind randomized controlled trial with a total follow up of 24 months.
Study population:
Adults (18-99) undergoing bowel resection with the formation of a temporary stoma.
Intervention:
A preventive mesh will be placed using a sublay keyhole technique (pre-peritoneal, retromuscular) at stoma formation. The mesh will be left in situ after stoma reversal and the hole in the mesh will be closed, to prevent incisional herniation.
Main study parameters/endpoints:
Nature and extent of the burden and the risks associated with participation, benefit and group relatedness:
The standard surgical procedure for the treatment of parastomal hernias is used in a prophylactic fashion. As this is standard care in parastomal hernias the risks are minimal. The mesh that is used is CE approved. The burden of participation in this study is minimal for the patient all follow-up visits coincide with the regular visits for colorectal cancer. Hence, no extra outpatient department visits, and even no additional diagnostics nor other medical procedures that could potentially burden the patient, are required.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
The intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma.
Device: Adhesix® monofilament polypropylene mesh (Bard Davol)
The control group will not receive a mesh and the stoma will be created according local protocol.
The intervention group will receive preventive mesh placement and in the control group no mesh is placed, the stoma is closed according to standard practise.
Occurrence of incisional hernia at the former stoma site.
Incidence of incisional hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Time frame: 24 months
Occurrence of parastomal hernia
Incidence of parastomal hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Time frame: 24 months
Occurence of prolapse
Incidence of prolapse Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Time frame: 24 months
Occurence of mesh infection
Incidence of mesh infection Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Time frame: 24 months
Occurence of wound infections
Incidence of wound infections Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Time frame: 24 months
Occurence of Seroma
Incidence of seroma Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Time frame: 24 months
Quality of life score
Quality of life postoperatively assessed through questionnaires. - EQ-5D-5L (0-25), lower is considered a better outcome
Time frame: 24 months
Quality of life score
Quality of life postoperatively assessed through questionnaires. - Carolina Comfort scale (0-40), lower is considered a better outcome.
Time frame: 24 months
Quality of life score
Quality of life postoperatively assessed through questionnaires. - EORTC QLQ-CR29 (0-228), lower is considered a better outcome.
Time frame: 24 months
Operation length
Time from start of the operation to finish (min), longer operation time can be an indication of a more complex procedure.
Time frame: during operation
Time to stoma reversal
Time between creation of the stoma and its reversal, will be expressed in days. (minimum of 14 days to a maximum of 730 days). It will be measured from creation of stoma to reversal, which is 6 weeks on average, if the stoma is not reversed within 24 months the patient is excluded. For it will not be able to reach the primary endpoint. Delay of reversal of the stoma may indicate that patient condition or other patient related factors are not optimal.
Time frame: time from stoma creation to reversal
Cost-effectiveness
Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term. Assessment will be performed using questionnaires; the iMCQ questionnaires for cost effectiveness analysis. The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.
Time frame: 24 months
Cost-effectiveness
Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term. Assessment will be performed using questionnaires; the iPCQ questionnaires for cost effectiveness analysis. The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.
Time frame: 24 months
Plan to share: Undecided
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Maastricht University Medical Center