Pre-surgery assessment for patient-related outcome after an extensive urological tumorsurgery, validation of the Erlangen-Index

Completed

• Conditions: C64; Malignant neoplasm of prostate; Overlapping lesion of urinary organs; C68.8; C61; Malignant neoplasm of kidney, except renal pelvis

• Registration Number: DRKS00032836
• Lead Sponsor: rologische Klinik im Waldkrankenhaus St. Marien, Erlangen

Brief Summary

The present study is based on the Erlangen pilot study, which developed an index for patients aged >70 years undergoing planned prostatectomy, nephrectomy and cystectomy. This index combines 6 tests and, in the analysis conducted there, was able to predict postoperative functional outcomes at 30 and 180 days, as well as mortality, but not complications significantly. In this study, the Erlangen Index was found to be predictive for functional outcomes at 180 days. However, for the other endpoints (postoperative outcomes at 30 days, complications and mortality), no significant predictive value was observed, except for a tendency towards predicting mortality. When considering the subgroups of surgeries, the results only partially align with those from the pilot study in Erlangen. According to this study, the relatively poor prediction of complications by the Erlangen Index was confirmed. Given that functional outcome is highly important for geriatric patients and that a 6-month follow-up provides a more comprehensive picture of a patient's postoperative status, the results for the 6-month follow-up may carry greater weight. The index proved to be a quick assessment requiring minimal expertise and personnel.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-02-01
• Results First Posted: 2022-11-13
• Study Start: 2023-10-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Age >=65
- Extensive urological/urooncoligical surgery (prostatectomy, cystectomy,
nephrectomy, revision, laparotomy, radioguided surgery)
- Patient or his relatives speak german
- Signed Consent of the patient regarding the study-related data collection up to 6 months after the initial assessment

Exclusion Criteria

none

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome after 30 days<br>Functional outcome after 180 days<br>Complications (during the hospital-stay)<br>Mortality rate after 180 days

Secondary Outcome Measures

Name	Time	Method
Validation of the Erlangen-Index