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Efficacy Study of Robotic Surgery for Rectal Cancer

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ClinicalTrials.gov Identifier: NCT01591798
Recruitment Status : Unknown
Verified May 2012 by Ji Won Park, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : May 4, 2012
Last Update Posted : May 7, 2012
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea

Brief Summary:
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 or disease Intervention/treatment Phase
Rectal Neoplasm Procedure: Robotic surgery Procedure: Laparoscopic surgery Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
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
Study Start Date : March 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Short-term postoperative outcome [ Time Frame: Within postoperative 30 days ]
  2. 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

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

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

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

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

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

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
Principal Investigator: Ji Won Park, Dr. National Cancer Center

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 Posted: May 4, 2012    Key Record Dates
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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases