Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis

Contipro

Status: Terminated

Conditions: Anastomosis, Leaking

Study type: Observational

Funder types: Other

Identifiers

NCT07490080

PT-DEH-1_02-24

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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