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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029194
Enrollment
500
Registered
2022-07-06
Start date
2022-08-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumours of the digestive tract C15 C16 C18 C19 C26 D13

Interventions

Group 1: This is an non-interventional observational study. All Patients will be screened by their pre and perioperative blood probes for further immune characterization.

Sponsors

Universitäsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Gastro-Intestinal anastomotic leakage classified as grade A-C analogous to the ISREC-Classification

Secondary

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

Countries

Germany

Contacts

Public ContactMaximilian Denzinger

Klinik für Allgemein- und ViszeralchirurgieUniversitätsklinikum Ulm

maximilian.denzinger@uniklinik-ulm.de073150053522

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026