PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
PROMISS
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedNovember 23, 2018
November 1, 2018
4 years
November 16, 2018
November 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (12)
Occurrence of parastomal hernia
24 months
Occurence of prolapse
24 months
Occurence of mesh infection
24 months
Occurence of wound infections
24 months
Occurence of Seroma
24 months
- +7 more secondary outcomes
Study Arms (2)
Adhesix® monofilament polypropylene mesh (Bard Davol) group
EXPERIMENTALThe intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma.
Control group
NO INTERVENTIONThe control group will not receive a mesh and the stoma will be created according local protocol.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Centre
Maastricht, Limburg, 6229 HX, Netherlands
Related Publications (1)
Vu BK, Lam J, Sherman MJ, Tam MS. Prophylactic Biosynthetic Retrorectus Mesh Placement During Stoma Reversal Reduces the Rate of Stoma Site Incisional Hernia. Perm J. 2024 Jun 14;28(2):16-25. doi: 10.7812/TPP/23.115. Epub 2024 Apr 23.
PMID: 38652519DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole D Bouvy, MD, PhD
Maastricht University Medical Centre, department of Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD candidate
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 23, 2018
Study Start
March 1, 2019
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
November 23, 2018
Record last verified: 2018-11