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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.