NCT03445936Active, not recruiting
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Source: ClinicalTrials.gov · Last updated 1 Feb 2024
Brief summary (registry, in English)
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Feb 2018
- Start date
- 13 Feb 2018
- Primary completion date
- 30 Oct 2022
- Lead sponsor
- University of Oulu
- Diseases
- Colorectal cancer
- NCT number
- NCT03445936
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 13 Feb 2018 to the primary completion date, 30 Oct 2022
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with T4b tumors which imposed a multi-organ resection
- Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
Other illness
- 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
- Metastatic disease with life expectancy of less than 12 months
Other
- Patient undergone emergency procedures
- Pregnancy or suspected pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jyväskylä Central Hospital Coordinator of this site? Confirm its status | Jyväskylä | Finland | Unknown status |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Seinäjoki Central Hospital Coordinator of this site? Confirm its status | Seinäjoki | Finland | Unknown status |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.