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OpenTrials
Completed

NCT Number: NCT01076387

Randomized Trial Comparing Robotic and Open Radical Cystectomy

The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Scheduled for radical cystectomy at MSKCC

Exclusion criteria

  • Prior pelvic or abdominal radiation therapy;
  • Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
  • Any clinical contraindication for Trendelenburg positioning

Treatment and study plan

Open radical cystectomy

Procedure

Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.

robotic-assisted radical cystectomy

Procedure

Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.

Primary outcomes

  1. To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.

    Time frame: intraoperative and 90-day postoperative period

Secondary outcomes

  1. To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.

    Time frame: 2 years

  2. Intra-operative performance (surgical time, blood loss)

    Time frame: time from anesthesia induction to final skin closure

  3. Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.

    Time frame: 1.5 years

  4. Bladder cancer recurrence (local, upper tract and distant disease)

    Time frame: 2 years

  5. complications grade 2-5

    Time frame: 2 years

    A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm.

  6. complication grade 3-5

    Time frame: 2 years

    Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2010
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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