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Efficacy Study of Robotic Surgery for Rectal Cancer

This study is currently recruiting participants.
Verified May 2012 by Ji Won Park, National Cancer Center, Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591798
First Posted: May 4, 2012
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea
  Purpose
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.

Condition Intervention Phase
Rectal Neoplasm Procedure: Robotic surgery Procedure: Laparoscopic surgery Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial

Further study details as provided by Ji Won Park, National Cancer Center, Korea:

Primary Outcome Measures:
  • Quality of mesorectal excision [ Time Frame: 7days after surgery (Pathologic report) ]
    Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34)


Secondary Outcome Measures:
  • Short-term postoperative outcome [ Time Frame: Within postoperative 30 days ]
  • Sexual and urinary function, Quality of life, Anorectal function [ Time Frame: Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months ]
    IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry

  • Long-term outcome [ Time Frame: Postoperative 36 months ]
    3 year disese-free survival


Estimated Enrollment: 146
Study Start Date: March 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic surgery
Proctectomy using robot
Procedure: Robotic surgery
Robotic assisted rectal resection
Other Name: da Vinci Surgical System
Active Comparator: Laparoscopic surgery
Conventional laparoscopic rectal resection
Procedure: Laparoscopic surgery
Laparoscopic assisted rectal resection

Detailed Description:
This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mid or low rectal cancer (within 9cm from anal verge)
  • pathologically proven as adenocarcinoma
  • written informed consent
  • no severe functional disability in lung and heart

Exclusion Criteria:

  • invading adjacent organ
  • distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.)
  • lateral pelvic lymph node metastasis
  • Have severe concomitant disease that might limit compliance or completion of the protocol.
  • Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer.
  • If female, be pregnant or breast feeding.
  • Hereditary colorectal cancer (HNPCC, FAP etc)
  • emergency operation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591798


Contacts
Contact: Jae Hwan Oh, Dr. 82-31-920-1637 jayoh@ncc.re.kr
Contact: Ji Won Park, Dr. 82-31-920-1894 sowisdom@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Jae Hwan Oh, Dr.    82-31-920-1637    jayoh@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Ji Won Park, Dr. National Cancer Center
  More Information

Responsible Party: Ji Won Park, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01591798     History of Changes
Other Study ID Numbers: NCC-CTS603
First Submitted: March 16, 2012
First Posted: May 4, 2012
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Ji Won Park, National Cancer Center, Korea:
Rectal cancer
Robotic surgery
Laparoscopic surgery

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases