Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction

NCT ID: NCT03280459

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Urothelial Carcinoma Cystectomy Urinary Diversion Complication of Surgical Procedure Complication, Postoperative Neobladder Ileal Conduit Robotic Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ileal Conduit

Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy

robot-assisted cystectomy

Intervention Type PROCEDURE

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

robot-assisted cystectomy

Intervention Type PROCEDURE

Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy

Interventions

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robot-assisted cystectomy

Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role lead

Responsible Party

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Christoph Schregel

Assistenzarzt Urologie / resident Departement of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Christoph Schregel, MD

Role: CONTACT

Orlando Burkhardt, MD

Role: CONTACT

+41792912821

Facility Contacts

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Christoph Schregel, M.D.

Role: primary

+4152264331 ext. +14766737873

Hubert John, M.D.

Role: backup

+41522662982

Other Identifiers

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2017-01260

Identifier Type: -

Identifier Source: org_study_id

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