To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh placement compared to no mesh placement. Secondly the incidence of parastomal hernias will be recorded and complications caused by preventive mesh placement…
ID
Source
Brief title
Condition
- Other condition
- Soft tissue therapeutic procedures
Synonym
Health condition
Aandoeningen van de buikwand
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal of this study is to investigate if the incidence of incisional
hernias at the former stoma site is reduced by preventive mesh placement.
Secondary outcome
- Occurrence of parastomal hernia
- Occurrence of stoma prolapse
- Occurrence of mesh infection
- Occurrence of wound infections
- Occurrence of seroma
- Quality of life score
- Operation length
- Time to stoma reversal
- Cost-effectiveness
Background summary
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, after stoma reversal has taken place, 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 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.
Study objective
To evaluate the incidence of incisional hernias after stoma reversal after
preventive mesh placement compared to no mesh placement. Secondly the incidence
of parastomal hernias will be recorded and complications caused by preventive
mesh placement will be evaluated. In addition, we aim to assess the effect of
preventive mesh placement on quality of life and healthcare cost reduction by
avoiding re-intervention.
Study design
A multicentre double blind randomized controlled trial with a total follow up
of 24 months.
The study will be conducted in the Maastricht University Medical Centre,
Rijnstate Ziekenhuis, Elkerliek Ziekenhuis, Canisius-Wilhelmina Ziekenhuis and
Zuyderland Medisch Centrum. The operations will be performed by experienced
surgeons.
The regular follow-up for colorectal carcinoma will be used for data gathering
and CT-scans made during this period will be evaluated for the primary outcome.
Intervention
A preventive mesh will be placed using a sublay keyhole technique
(pre-peritoneal, retromuscular) at stoma formation. The mesh (versatex mesh
15x15cm) will be left in situ after stoma reversal and the hole in the mesh
will be closed, to prevent incisional herniation. The bowel resection or stoma
formation will be performed as planned and is not further altered by the
intervention procedure.
Study burden and risks
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.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years
- Diagnosed with colorectal carcinoma
- Bowel resection following stoma formation, intended to be temporary.
- Elective surgery
- ASA-score I-III
- Signed informed consent
Exclusion criteria
- Emergency operation
- Peritonitis (i.e. bowel perforation)
- Bowel obstruction
- A life expectancy of less than 2 years (distant metastasis i.e. located in the liver, peritoneum, lung, cerebral or bone)
- Earlier hernia repair with mesh placed in a 10cm proximity of the future stoma site.
- Chronic use of antibiotics
- Chronic use of immunosuppressive medication
- ASA-score IV or above
- Not able to sign informed consent
- Patient being unable to speak Dutch
- Patient allergic to one of the components of the mesh
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63259.068.17 |