Prediction of intestinal anastomotic leakage via liquid biopsy - a prospective cohort study (PRAY)

Recruiting

• Conditions: C18; C19; C26; D13; Tumours of the digestive tract; C15; C16; Malignant neoplasm of oesophagus; Malignant neoplasm of stomach; Malignant neoplasm of colon

• Registration Number: DRKS00029194
• Lead Sponsor: niversitäsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patients scheduled for elective surgery with at least one intestinal anastomosis
- Ability of subject to understand character of the study
- Written informed consent
- Age =18 years

Exclusion Criteria

- Emergency Operations
- Immunodefiency
- Immunsuppresive therapy (>7,5 mg Prednisolon or äquivalent) within four weeks prior to surgery
- Biological therapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastro-Intestinal anastomotic leakage classified as grade A-C analogous to the ISREC-Classification

Secondary Outcome Measures

Name	Time	Method
Postoperative complications graded according to the Clavien-Dindo classification:<br>- Surgical Site Infection according to CDC (Center for Disease Control): Superficial, deep and organ/space infection<br>- Infectious complications (Pneumonia, Urinary tract infection, Bacteremia) <br>- Bleeding<br>- Thromboembolic complications (venous thrombosis, pulmonary embolism, heart attack, stroke)<br>- Ischemic complication (bowel infarction) <br>- Bowel paralysis, delayed gastric emptying, postoperative ileus<br>- Organ failure (cardiocirculatory, pulmonary, renal failure, hepatic failure)