Rectum CancerNCT03445936
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
A study testing Parietene Macro and Permacol in people with Rectum Cancer, run by University of Oulu at 4 sites in Finland.
Trial summary
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- Parietene Macro and Permacol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFinland
- Study dates
- 13 Feb 2018to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
- 18 years or older
- Patient has a life expectancy of at least 12 months.
- Patient signs the Informed consent and agrees to attend all study visits
Who cannot join
- Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
- Patients with concurrent or previous malignant tumors within 5 years before study enrollment
- Patients with T4b tumors which imposed a multi-organ resection
- Patient undergone emergency procedures
- Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- Metastatic disease with life expectancy of less than 12 months
- Pregnancy or suspected pregnancy
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Jyvaskyla Central Hospital
Jyväskylä
Oulu University Hospital
Oulu
Seinajoki Central Hospital
Seinäjoki
Tampere University Hospital
Tampere
About this study
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
Read the detailed description
Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.
The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.
- Conditions
- Rectum Cancer
- Being tested
- Parietene Macro, Permacol
- Keywords
- loop-ileostomy reversal, hernia prevention
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietene MacroDevice
Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
PermacolDevice
Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
| Study group | Role | What they receive |
|---|---|---|
| Parietene Macro | Active comparator | Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. Receives: Device: Parietene Macro |
| Permacol | Active comparator | Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. Receives: Device: Permacol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
The incidence of surgical site infections at 30 days follow up
Measured: 30 days
Incisional hernia
Incidence of incisional hernia
Measured: 10 months
Secondary outcomes (7)
Complications classified by Clavien-Dindo classification
Clavien-Dindo I-V complications at 30 days follow-up
Measured: 30 days
Re-operation rate
Demand for re-operations related to mesh or complications
Measured: 5 years
Operative time
Time (min) needed for operation and application of mesh/implant
Measured: 30 days
Length of stay
Length of stay at the hospital after the operation
Measured: 30 days
Quality of life measured by RAND-36 survey
Quality of life after the operation measured by RAND 36
Measured: 5 years
Incidence of hernia
Incidence of incisional hernia
Measured: 5 years
Cost analysis
Analysis of costs to both individual and community
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start13 Feb 2018
- Primary completion30 Oct 2022
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- 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
- This is a prospective randomized controlled multicenter trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Mäkäräinen, University of Oulu
- Investigators
- Elisa Mäkäräinen-Uhlbäck, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445936
- Sponsor's protocol ID
- 317/2017
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2018
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makarainen EJ, Wiik HT, Kossi JAO, Pinta TM, Mantymaki LJ, Mattila AK, Nikki MJ, Jarvinen JE, Ohtonen PP, Rautio TT. Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial). Br J Surg. 2024 Jan 3;111(1):znad362. doi: 10.1093/bjs/znad362.
PubMed 37944025
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
- ClinicalTrials.gov ID
- NCT03445936
- Acronym / sponsor ID
- 317/2017
- Conditions
- Rectum Cancer
- Keywords
- loop-ileostomy reversal, hernia prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Feb 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.
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
Detailed description
Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.
The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Parietene Macro | Active comparator | Device: Parietene MacroParietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. |
| Permacol | Active comparator | Device: PermacolPermacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
- 18 years or older
- Patient has a life expectancy of at least 12 months.
- Patient signs the Informed consent and agrees to attend all study visits
Key exclusion criteria (7 listed)
- Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
- Patients with concurrent or previous malignant tumors within 5 years before study enrollment
- Patients with T4b tumors which imposed a multi-organ resection
- Patient undergone emergency procedures
- Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
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 |
|---|---|---|
| Parietene MacroParietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia. | Device | Parietene Macro |
| PermacolPermacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia. | Device | Permacol |
Primary outcome
Surgical site infection
Time frame: 30 days
The incidence of surgical site infections at 30 days follow up
Incisional hernia
Time frame: 10 months
Incidence of incisional hernia
7 secondary outcomes
Complications classified by Clavien-Dindo classification
Time frame: 30 days
Re-operation rate
Time frame: 5 years
Operative time
Time frame: 30 days
Length of stay
Time frame: 30 days
Quality of life measured by RAND-36 survey
Time frame: 5 years
Incidence of hernia
Time frame: 5 years
Cost analysis
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 37944025Makarainen EJ, Wiik HT, Kossi JAO, Pinta TM, Mantymaki LJ, Mattila AK, Nikki MJ, Jarvinen JE, Ohtonen PP, Rautio TT. Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial). Br J Surg. 2024 Jan 3;111(1):znad362. doi: 10.1093/bjs/znad362.
- Individual participant dataSharing planned: No
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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.
Elisa Mäkäräinen-Uhlbäck principal investigator
Oulu University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parietene Macro and Permacol in people with Rectum Cancer, run by University of Oulu at 4 sites in Finland.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445936, which also lists 1 linked publication.
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 1 Feb 2024.