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)
- Conditions
- C76.2Abdomen
- Registration Number
- DRKS00013035
- Lead Sponsor
- niversitätsklinikum Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 347
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
1.American Society of Anesthesiologists (ASA) grade > 3
2.Language barrier that impedes follow-up
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Postoperative complications, survival, quality of life, cancer associated symptoms