Parastomal HerniaNCT03799939
Chimney Trial of Parastomal Hernia Prevention
A study testing Intervention group in people with Parastomal Hernia and Rectal Adenocarcinoma, run by University of Oulu at 7 sites in 2 countries.
Trial summary
Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia, Rectal Adenocarcinoma, Abdominoperineal Resection
- What is being tested?
- Intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 Feb 2019to Jul 2026
- 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
- 18 years or older
- Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
- Patient has a life expectancy of at least 12 months.
- Patient must sign Informed consent before any study procedures and agrees to attend all study visits
Who cannot join
- Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
- Complication requiring laparotomy during post surgery treatment at surgical ward after APR
- 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
Show all 14Show fewer
- Patient undergoing emergency procedures
- Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- Metastatic disease with no possibility of curative surgery
- Pregnant or suspected pregnancy
- Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
- Active abdominal infection at the time of surgery
- Previous surgery at the colostomy site
- Language barrier or other reasons why informed consent is not possible
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Finland6 sites
Helsinki University Hospital
Helsinki
Keski-Suomi Central Hospital
Jyväskylä
Oulu University Hospital
Oulu
Seinäjoki Central Hospital
Seinäjoki
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention
Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
Read the detailed description
The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.
Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.
- Being tested
- Intervention group
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupDevice
Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia. Receives: Device: Intervention group |
| Control group | No intervention | Participants in control group are operated with no preventive mesh. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of parastomal hernia
Incidence of parastomal hernia at 12 months follow up
Measured: 12 months
Secondary outcomes (12)
Incidence of parastomal hernia at long term follow up
Incidence of parastomal hernia during 5 years of follow up
Measured: 5 years
Surgical site infection rate
Surgical site infections measured by Clavien-Dindo Classification
Measured: 30 days
Complications
Complications measured by Clavien-Dindo Classification
Measured: 30 days
Stoma related complications
Stoma related complications measured by Clavien-Dindo Classification
Measured: 5 years
Reoperation rate
Need for reoperations
Measured: 5 years
Operative time
Operative time
Measured: 1 day
Length of stay
Length of stay at the hospital
Measured: 30 days
Rand 36 quality of life
Quality of life measured by Rand-36 quality of life questionnaire
Measured: 5 years
Quality of life measured by Colostomy impact score
Quality of life measured by Colostomy impact score
Measured: 5 years
Medico-economic substudy
Medico-economic substudy including both short and long term costs included in both groups
Measured: 5 years
Radiological substudy of stoma distance
Distance of stoma from midline defined by umbilicus
Measured: 3 years
Radiological substudy of adipose tissue thickness
Thickness of adipose tissue on computer tomography scan on contralateral site of stoma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start5 Feb 2019
- Primary completion30 Aug 2022
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies 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
- Chimney trial is a prospective randomized controlled multicenter trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
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, M.D., Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799939
- Sponsor's protocol ID
- 305/2018
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2019
- 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 E, Jarvinen J, Kossi J, Nikberg M, Wiik H, Carpelan-Holmstrom M, Pinta T, Lehto K, Nikki M, Ohtonen P, Rautio T. Prevention of Parastomal Hernia With Funnel-Shaped Intra-Abdominal Mesh vs No Mesh for Rectal Adenocarcinoma Surgery: 3-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):584-588. doi: 10.1001/jamasurg.2026.1036.
PubMed 42018309Makarainen E, Wiik H, Nikberg M, Kossi J, Carpelan-Holmstrom M, Pinta T, Lehto K, Nikki M, Jarvinen J, Ohtonen P, Rautio T. Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh: The Chimney Randomized Clinical Trial. JAMA Surg. 2024 Nov 1;159(11):1244-1250. doi: 10.1001/jamasurg.2024.3260.
PubMed 39196580Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y.
PubMed 31779699
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
- Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention
- ClinicalTrials.gov ID
- NCT03799939
- Acronym / sponsor ID
- 305/2018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Jan 2019 (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.
Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
Detailed description
The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.
Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Chimney trial is a prospective randomized controlled multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Device: Intervention groupPolyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia. |
| Control group | No intervention | –Participants in control group are operated with no preventive mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
- Patient has a life expectancy of at least 12 months.
- Patient must sign Informed consent before any study procedures and agrees to attend all study visits
Key exclusion criteria (14 listed)
- Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
- Complication requiring laparotomy during post surgery treatment at surgical ward after APR
- 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
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 |
|---|---|---|
| Intervention groupPolyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia. | Device | Intervention group |
Primary outcome
Incidence of parastomal hernia
Time frame: 12 months
Incidence of parastomal hernia at 12 months follow up
12 secondary outcomes
Incidence of parastomal hernia at long term follow up
Time frame: 5 years
Surgical site infection rate
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: 1 day
Length of stay
Time frame: 30 days
Rand 36 quality of life
Time frame: 5 years
Quality of life measured by Colostomy impact score
Time frame: 5 years
Medico-economic substudy
Time frame: 5 years
Radiological substudy of stoma distance
Time frame: 3 years
Radiological substudy of adipose tissue thickness
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 42018309Makarainen E, Jarvinen J, Kossi J, Nikberg M, Wiik H, Carpelan-Holmstrom M, Pinta T, Lehto K, Nikki M, Ohtonen P, Rautio T. Prevention of Parastomal Hernia With Funnel-Shaped Intra-Abdominal Mesh vs No Mesh for Rectal Adenocarcinoma Surgery: 3-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):584-588. doi: 10.1001/jamasurg.2026.1036.
- Derived from this study: PubMed 39196580Makarainen E, Wiik H, Nikberg M, Kossi J, Carpelan-Holmstrom M, Pinta T, Lehto K, Nikki M, Jarvinen J, Ohtonen P, Rautio T. Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh: The Chimney Randomized Clinical Trial. JAMA Surg. 2024 Nov 1;159(11):1244-1250. doi: 10.1001/jamasurg.2024.3260.
- Derived from this study: PubMed 31779699Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y.
- 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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Parastomal Hernia and Rectal Adenocarcinoma, run by University of Oulu at 7 sites in 2 countries.
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 14 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 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 7 sites in Finland, Sweden. 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?
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: 12 months). 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 NCT03799939, which also lists 3 linked publications.
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.