Hospital costs of complications following cystectomy

Not Applicable

Completed

• Conditions: Surgical removal of the bladder; Complications following cystectomy; Bladder cancer; Surgery - Surgical techniques; Renal and Urogenital - Other renal and urogenital disorders; Anaesthesiology - Anaesthetics; Cancer - Bladder

• Registration Number: ACTRN12622000057785
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-01
• Study Start: 2022-01-18
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

Inclusion criteria will include
1. Radical cystectomy with or without ileal conduit
2. Radical cystoprostatectomy with or without ileal/sigmoid conduit
3. Radical cystectomy with neobladder
4. Radical cystoprostatectomy with neobladder

Both open and laparoscopic techniques will be included. All reconstructions of the urinary tract will be included (e.g., ileal conduit, neobladder reconstruction or continent urinary reservoir).

Exclusion Criteria

Excluded patients will include:

1. Patients who have undergone a partial cystectomy
2. If the cystectomy was secondary to another major procedure (e.g., pelvic exenteration, cystectomy with hysterectomy and oophorectomy)
3. Cystectomy secondary to trauma.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Costs of complications as a composite outcome defined as the hospital costs associated with the index surgery. <br><br>All costs related to the index admission for radical cystectomy and any consequent readmissions will be included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs will be calculated using an activity-based costing methodology. Only in-hospital costs are considered, with both direct and indirect costs assessed to produce a total cost for each patient. Costs for each patient will be obtained from the Austin Health Department of Finance, which maintain an itemised prospective database of all hospital expenses related to each patient.[Costs will be calculated from day of surgery to hospital discharge. Readmissions will be considered within 30 days of discharge from the index admission.]

Secondary Outcome Measures

Name	Time	Method
Complications following radical cystectomy. Complications will be assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include infection, haemorrhage, death, etc. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.[Complications will be retrospectively collected from the patient medical records at hospital discharge. The duration period over which complications will be collected are from the completion of surgery to hospital discharge for the index admission.];Patient mortality after radical cystectomy.[Any observed mortality will be recorded after surgery until the last observation day which will be set a-priori as 31 Oct 2021. This will result in an observation follow up period of at least months post index surgery. ]