Clinical trial NCT03750942: PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
Official title: PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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:

* Primary: Incidence of incisional hernias after stoma reversal
* Secondary: Quality of life, stoma related prolapse or parastomal herniation, cost effectiveness and mesh related complications.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of incisional hernia at the former stoma site.
timeFrame: 24 months
Secondary outcomes:
measure: Occurrence of parastomal hernia
timeFrame: 24 months
measure: Occurence of prolapse
timeFrame: 24 months
measure: Occurence of mesh infection
timeFrame: 24 months
measure: Occurence of wound infections
timeFrame: 24 months
measure: Occurence of Seroma
timeFrame: 24 months
measure: Quality of life score
timeFrame: 24 months
measure: Quality of life score
timeFrame: 24 months
measure: Quality of life score
timeFrame: 24 months
measure: Operation length
timeFrame: during operation
measure: Time to stoma reversal
timeFrame: time from stoma creation to reversal
measure: Cost-effectiveness
timeFrame: 24 months
measure: Cost-effectiveness
timeFrame: 24 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre, department of Surgery
name: Nicole D Bouvy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: