Incisional HerniaPROMISSNCT03750942
PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
A study testing Adhesix® monofilament polypropylene mesh (Bard Davol) in people with Incisional Hernia, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Adhesix® monofilament polypropylene mesh (Bard Davol)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2019to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229 HX
Nicole Bouvy, MD, PhD, 043-3875492, n.bouvy@mumc.nl
About this study
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.
Read more
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
- Being tested
- Adhesix® monofilament polypropylene mesh (Bard Davol)
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesix® monofilament polypropylene mesh (Bard Davol)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.
| Study group | Role | What they receive |
|---|---|---|
| Adhesix® monofilament polypropylene mesh (Bard Davol) group | Experimental | The intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma. Receives: Device: Adhesix® monofilament polypropylene mesh (Bard Davol) |
| Control group | No intervention | The control group will not receive a mesh and the stoma will be created according local protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (12)
Occurrence of parastomal hernia
Incidence of parastomal hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Measured: 24 months
Occurence of prolapse
Incidence of prolapse Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Measured: 24 months
Occurence of mesh infection
Incidence of mesh infection Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Measured: 24 months
Occurence of wound infections
Incidence of wound infections Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Measured: 24 months
Occurence of Seroma
Incidence of seroma Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
Measured: 24 months
Quality of life score
Quality of life postoperatively assessed through questionnaires.
- EQ-5D-5L (0-25), lower is considered a better outcome
Measured: 24 months
Quality of life score
Quality of life postoperatively assessed through questionnaires.
- Carolina Comfort scale (0-40), lower is considered a better outcome.
Measured: 24 months
Quality of life score
Quality of life postoperatively assessed through questionnaires.
- EORTC QLQ-CR29 (0-228), lower is considered a better outcome.
Measured: 24 months
Operation length
Time from start of the operation to finish (min), longer operation time can be an indication of a more complex procedure.
Measured: during operation
Time to stoma reversal
Time between creation of the stoma and its reversal, will be expressed in days. (minimum of 14 days to a maximum of 730 days). It will be measured from creation of stoma to reversal, which is 6 weeks on average, if the stoma is not reversed within 24 months the patient is excluded. For it will not be able to reach the primary endpoint. Delay of reversal of the stoma may indicate that patient condition or other patient related factors are not optimal.
Measured: time from stoma creation to reversal
Cost-effectiveness
Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term.
Assessment will be performed using questionnaires; the iMCQ questionnaires for cost effectiveness analysis.
The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.
Measured: 24 months
Cost-effectiveness
Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term.
Assessment will be performed using questionnaires; the iPCQ questionnaires for cost effectiveness analysis.
The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastiaan van Steensel, Maastricht University Medical Center
- Investigators
- Nicole D Bouvy, MD, PhD, Principal investigator, Maastricht University Medical Centre, department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750942
- Sponsor's protocol ID
- NL63259.068.17
- Acronym
- PROMISS
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
- ClinicalTrials.gov ID
- NCT03750942
- Acronym / sponsor ID
- PROMISS / NL63259.068.17
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adhesix® monofilament polypropylene mesh (Bard Davol) group | Experimental | Device: Adhesix® monofilament polypropylene mesh (Bard Davol)The intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma. |
| Control group | No intervention | –The control group will not receive a mesh and the stoma will be created according local protocol. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Diagnosed with colorectal carcinoma
- Bowel resection following stoma formation, intended to be temporary.
- Elective surgery
- ASA-score I-III
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Adhesix® monofilament polypropylene mesh (Bard Davol) group |
Primary outcome
Occurrence of incisional hernia at the former stoma site.
Time frame: 24 months
Incidence of incisional hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
12 secondary outcomes
Occurrence of parastomal hernia
Time frame: 24 months
Occurence of prolapse
Time frame: 24 months
Occurence of mesh infection
Time frame: 24 months
Occurence of wound infections
Time frame: 24 months
Occurence of Seroma
Time frame: 24 months
Quality of life score
Time frame: 24 months
Quality of life score
Time frame: 24 months
Quality of life score
Time frame: 24 months
Operation length
Time frame: during operation
Time to stoma reversal
Time frame: time from stoma creation to reversal
Cost-effectiveness
Time frame: 24 months
Cost-effectiveness
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Incisional Hernia
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole D Bouvy, MD, PhD principal investigator
Maastricht University Medical Centre, department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesix® monofilament polypropylene mesh (Bard Davol) in people with Incisional Hernia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole D Bouvy, MD, PhD (+3143-3875492, n.bouvy@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of incisional hernia at the former stoma site. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.