PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Incisional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Adhesix® monofilament polypropylene mesh (Bard Davol) group

The intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma.

Group Type EXPERIMENTAL

Adhesix® monofilament polypropylene mesh (Bard Davol)

Intervention Type DEVICE

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.

Control group

The control group will not receive a mesh and the stoma will be created according local protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adhesix® monofilament polypropylene mesh (Bard Davol)

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No