PerImmuncheck: Immune Checkpoint Proteins as Predictive Markers of Postoperative Outcomes After Colorectal Surgery (Pilot Study)

PerImmuncheck: Immune Checkpoint Proteins as Predictive Markers of Postoperative Outcomes After Colorectal Surgery (Pilot Study) - PerImmuncheck

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035071

Enrollment

Registered

2024-09-12

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C26.0

Interventions

Group 1: Patients undergoing elective colorectal surgeries - blood analysis at screening (baseline) and first, third and fifth postoperative day - questionnaire SIRS, GCS, QoR-15 at third postoperativ

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Reason and type of planned procedure: elective colorectal surgical procedure - Written informed consent (participant information, consent form, data privacy statement) provided by the patient at the time of inclusion in the study

Exclusion criteria

Exclusion criteria: - Chronic glucocorticoid therapy (not perioperative glucocorticoid therapy) - Immune cell transfer, e.g., CAR-T cells and NK cells within the last year - Therapy with antibodies against immune checkpoint proteins, such as PD-1 (Nivolumab, Pembrolizumab, Durvalumab, Atezolizumab, Avelumab), PD-L1 (Ipilimumab, Tremelimumab), and CTLA-4 (Ipilimumab) - Active tumors not originating from the colon and/or rectum - Procedures where the planned surgical field extends significantly beyond the colon and rectum, e.g., exenteration

Design outcomes

Primary

Measure	Time frame
QoR-15 Questionnaire (Patient Reported Outcome Measure)	—

Secondary

Measure	Time frame
- Need for treatment in the ICU or IMC within the first three days after surgery - Need for late treatment in the ICU or IMC between the fourth and seventh day after surgery (if not previously treated in the ICU and/or IMC) - Progress assessment based on clinical scores at the time of sampling and at hospital discharge (SIRS, GCS, QoR-15) - Progress assessment based on the pain scale daily until discharge, following the WHO pain ladder according to the SOP of the Department of Surgery - Bowel passage - Anastomotic leakage (grade) - Nosocomial infection/sepsis within the first seven days after surgery - Surgical site infection (SSI) - Non-infectious acute organ dysfunction within the first seven days after surgery - Length of hospital stay - Hospital mortality - Functional outcome after 90 days (Gastrointestinal Quality of Life Index (GIQLI) questionnaire)	—

Measure

Time frame

- Need for treatment in the ICU or IMC within the first three days after surgery - Need for late treatment in the ICU or IMC between the fourth and seventh day after surgery (if not previously treated in the ICU and/or IMC) - Progress assessment based on clinical scores at the time of sampling and at hospital discharge (SIRS, GCS, QoR-15) - Progress assessment based on the pain scale daily until discharge, following the WHO pain ladder according to the SOP of the Department of Surgery - Bowel passage - Anastomotic leakage (grade) - Nosocomial infection/sepsis within the first seven days after surgery - Surgical site infection (SSI) - Non-infectious acute organ dysfunction within the first seven days after surgery - Length of hospital stay - Hospital mortality - Functional outcome after 90 days (Gastrointestinal Quality of Life Index (GIQLI) questionnaire)

—

Countries

Germany

Contacts

Public ContactVerena Schneider-Lindner

Klinik für Anästhesie, Operative Intensivmedizin und Schmerzmedizin, UMM, Medizinische Fakultät Mannheim der Universität Heidelberg

verena.schneider-lindner@umm.de+496213832755

Outcome results

None listed

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