Skip to content

Multicenter prospective cohort study of PATient-Reported Outcomes and complications following major abdominal Neoplastic Surgery (PATRONUS) - a CHIR-Net Student-Initiated German Medical Audit trial (CHIR-Net SIGMA trial)

Multicenter prospective cohort study of PATient-Reported Outcomes and complications following major abdominal Neoplastic Surgery (PATRONUS) - a CHIR-Net Student-Initiated German Medical Audit trial (CHIR-Net SIGMA trial) - PATRONUS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00013035
Enrollment
1000
Registered
2017-10-26
Start date
2018-02-28
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

C76.2

Interventions

Group 1: Patients undergoing an abdominal surgery due to carcinoma are monitored for short-term and long-term follow-up and so-called patient reported outcomes (PROs) No interventions will be carried

Sponsors

Universitätsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective abdominal surgery for confirmed or suspected malignancy 2.Ability of subject to understand character of the study 3.Laparoscopic or open surgery or any variant (laparoscopic-assisted, laparoscopic-thoracoscopic etc.) 4.Written informed consent 5.Age =18 years

Exclusion criteria

Exclusion criteria: 1.American Society of Anesthesiologists (ASA) grade > 3 2.Language barrier that impedes follow-up

Design outcomes

Primary

MeasureTime frame
Investigation of the relationship between clinical endpoints (postoperative complication rate after Dindo-Clavien) and the two new patient-reported outcomes PRO-CTCAE and the computerised adaptive testing (CAT) version of the quality-of-life curve EORTC QLQ-C30 in patients with abdominal oncological operations.

Secondary

MeasureTime frame
Postoperative complications, survival, quality of life, cancer associated symptoms

Countries

Germany

Contacts

Public ContactAndré Mihaljevic

Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm

andre.mihaljevic@med.uni-heidelberg.de+4973150053502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026