PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-il… (NCT03445936) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Finland100 participantsStarted 2018-02-13
Plain-language summary
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
Who can participate
Age range18 Years
SexALL
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:
* 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
Exclusion Criteria:
* 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