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

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.

Conditions

• Incisional Hernia

Interventions

DEVICE

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.

Sponsors & Collaborators

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Nicole D Bouvy, MD, PhD · Maastricht University Medical Centre, department of Surgery

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2023-03-01

Completion

2023-03-01

Countries

• Netherlands

Study Locations