Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction (iRARC-KSW)

Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion

Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.

Study Overview

• Status: Recruiting
• Conditions: Complication of Surgical Procedure; Urothelial Carcinoma; Urinary Diversion; Robotic Surgical Procedures; Complication, Postoperative; Cystectomy; Ileal Conduit; Neobladder
• Intervention / Treatment: Procedure: robot-assisted cystectomy

Detailed Description

The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Christoph Schregel, MD; Email: christophschregel@gmx.de
• Study Contact Backup: Name: Orlando Burkhardt, MD; Phone Number: +41792912821

Study Locations

• Switzerland
  • Winterthur, Switzerland, 8401
    • Recruiting
    • Kantonsspital Winterthur
    • Contact: Christoph Schregel, M.D.; Phone Number: +14766737873 +4152264331; Email: christophschregel@gmx.de
    • Contact: Hubert John, M.D.; Phone Number: +41522662982; Email: hubert.john@ksw.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Onkologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy

Description

Inclusion Criteria:

• age 18 years
• informed consent for operation and data use
• Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy

Exclusion Criteria:

• age <18 years
• declined informed consent / data use
• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ileal Conduit; Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy	Procedure: robot-assisted cystectomy; Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
Neobladder; Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy	Procedure: robot-assisted cystectomy; Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	deviations from normal postoperative course ["Clavien-Dindo" Grade]	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of tumor recurrence	Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)	through study completion, an average of 5 years
Quality of Life urology specific	EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer	1 year
Quality of Life overall	EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients	1 year
Operation Time	duration of operation [min]	expected 4-8 hours
Postoperative Death by any cause	Death by any cause [n/months]	through study completion, an average of 5 years
Pouch capacity	interventional measurement of pouch capacity with pressure recording catheter [ml]	1 year
Type of tumor-recurrence	Location of tumor recurrence (local, metastasis)	through study completion, an average of 5 years
Blood loss	blood loss during operation [ml]	expected 4-8 hours
Time to recurrence	time until recurrence of tumor [months]	through study completion, an average of 5 years
Tumor specific death	Time to tumor specific death [months]	through study completion, an average of 5 years
Preoperative Tumor staging	Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)	90 days
Postoperative Tumor staging	Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)	90 days
Pouch-pressure	interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter	1 year
Postvoid residual urine	Residual urin after voiding [ml]	1 year
Functional length of urethral sphincter	interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter	1 year
Functional pressure of urethral sphincter	interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter	1 year

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2017-01260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No