TerminatedNot Applicable

Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis

Stopped: safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design

Czechia20 participantsStarted 2024-10-23

Plain-language summary

A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.

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 * Age ≥ 18 years * Patients with histologically confirmed rectal adenocarcinoma (\< 15 cm from the anal margin) following rectal resection with colorectal anastomosis * Patients with or without neoadjuvant therapy * Patients willing and able to provide written informed consent * Patients able to communicate effectively with the investigator in the local language and to understand and comply with the study requirements. Exclusion criteria * Age \< 18 years * Pregnant or breastfeeding women * Patients in the terminal stage of life * Subjects with known hypersensitivity or allergy to any component of the investigational product or to the administered antibiotics * Acute surgery * Preventive ostomy * Other malignancies * Incomplete data

What they're measuring

Incidence of anastomotic leak

Timeframe: 30 days

Trial details

NCT IDNCT07490080

SponsorContipro Pharma a.s.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-30

View on ClinicalTrials.gov More Anastomosis, Leaking trials