Rectal AdenocarcinomaNCT03527784
Prestoma-Trial for Parastomal Hernia Prevention
A study testing Parietene Macro, Parietex Parastomal and Dynamesh IPST in people with Rectal Adenocarcinoma, run by University of Oulu at 6 sites in Finland.
Trial summary
Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Parietene Macro, Parietex Parastomal and Dynamesh IPST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesFinland
- Study dates
- 3 May 2018to 29 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominoperineal resection for rectal cancer with permanent end colostomy, either by laparoscopic technique or robotic assistance
- 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
- Abdominoperineal resection by laparotomy or conversion to laparotomy
- Patient with a comorbid illness or condition that would preclude 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 impose a multi-organ resection
- Rectal malignancy other than adenocarcinoma
- Potentially curable resection not possible
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- Patient undergoing emergency procedures
- Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- Metastatic disease with life expectancy of less than 1 year
- Pregnant or suspected pregnancy
- Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
Helsinki University Hospital
Helsinki
Jyväskylä Central Hospital
Jyväskylä
Oulu University Hospital
Oulu
Seinäjoki Central Hospital
Seinäjoki
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma
Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
Read the detailed description
Parastomal hernia after permanent colostomy formation is a common problem. The European Hernia Society recommends the use of prophylactic mesh when the stoma is constructed. So far, there're no trials comparing the methods to prevent the parastomal hernia.
Prestoma Trial is designed to compare the most researched retromuscular mesh (Parietene Macro by Medtronic) with two different types of intraperitoneal meshes (Parietex Parastomal by Medtronic and Dynamesh IPST) in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Parietene Macro, Parietex Parastomal, Dynamesh IPST
- Keywords
- rectal adenocarcinoma, abdominoperineal resection, hernia prophylaxis
- 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 used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
Parietex ParastomalDevice
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
Dynamesh IPSTDevice
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
| Study group | Role | What they receive |
|---|---|---|
| Parietene Macro | Active comparator | Parietene Macro is a macroporous synthetic mesh. Receives: Device: Parietene Macro |
| Parietex Parastomal | Active comparator | Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments. Receives: Device: Parietex Parastomal |
| Dynamesh IPST | Active comparator | Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia. Receives: Device: Dynamesh IPST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of parastomal hernia
The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.
Measured: 1 year
Secondary outcomes (7)
Surgical infections
Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection.
Measured: 30 days
Complications
The incidence of complications defined by Clavien-Dindo Classification
Measured: 30 days
Stoma related complications
Any complications related to stoma
Measured: 5 years
Reoperation rate
Reoperation needed for any reason related to previous surgery
Measured: 5 years
Operative time
Total time needed in operation theatre and time needed for mesh application
Measured: 30 days
Length of stay
Length of stay at the hospital.
Measured: 30 days
Quality of Life measured by RAND 36
Quality of life measured by The RAND 36-Item Health Survey 1.0 which assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions with a scale 0-100, higher the score, better the quality of life.
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 posted17 May 2018
- Study start3 May 2018
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Why it stopped: Parastomal Parietex withdrawn from market by the manufacturer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies 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
- Prestoma is a prospective randomized controlled multicenter trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Makarainen-Uhlback, University of Oulu
- Investigators
- Elisa Mäkäräinen-Uhlbäck, M.D., Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527784
- Sponsor's protocol ID
- 85/2018
- Status last verified
- Nov 2018
- First submitted
- 2 May 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03527784
- Acronym / sponsor ID
- 85/2018
- Conditions
- Rectal Adenocarcinoma
- Keywords
- rectal adenocarcinoma, abdominoperineal resection, hernia prophylaxis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Parastomal Parietex withdrawn from market by the manufacturer.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 17 May 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.
Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
Detailed description
Parastomal hernia after permanent colostomy formation is a common problem. The European Hernia Society recommends the use of prophylactic mesh when the stoma is constructed. So far, there're no trials comparing the methods to prevent the parastomal hernia.
Prestoma Trial is designed to compare the most researched retromuscular mesh (Parietene Macro by Medtronic) with two different types of intraperitoneal meshes (Parietex Parastomal by Medtronic and Dynamesh IPST) in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prestoma is a prospective randomized controlled multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Parietene Macro | Active comparator | Device: Parietene MacroParietene Macro is a macroporous synthetic mesh. |
| Parietex Parastomal | Active comparator | Device: Parietex ParastomalParietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments. |
| Dynamesh IPST | Active comparator | Device: Dynamesh IPSTDynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Abdominoperineal resection for rectal cancer with permanent end colostomy, either by laparoscopic technique or robotic assistance
- 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 (11 listed)
- Abdominoperineal resection by laparotomy or conversion to laparotomy
- Patient with a comorbid illness or condition that would preclude 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 impose a multi-organ resection
- Rectal malignancy other than adenocarcinoma
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 used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh. | Device | Parietene Macro |
| Parietex ParastomalParietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia. | Device | Parietex Parastomal |
| Dynamesh IPSTDynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia | Device | Dynamesh IPST |
Primary outcome
Incidence of parastomal hernia
Time frame: 1 year
The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.
7 secondary outcomes
Surgical infections
Time frame: 30 days
Complications
Time frame: 30 days
Stoma related complications
Time frame: 5 years
Reoperation 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
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Parastomal Parietex withdrawn from market by the manufacturer.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- 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, M.D. principal investigator
Oulu University Hospital
6 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, Parietex Parastomal and Dynamesh IPST in people with Rectal Adenocarcinoma, run by University of Oulu at 6 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 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: stopped early, as of the sponsor's last update on 5 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 6 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?
The study was stopped early (reason given: Parastomal Parietex withdrawn from market by the manufacturer.). Results are not available in the source record.
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?
Incidence of parastomal hernia (time frame: 1 year). 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 5 Nov 2018.