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Efficacy Study of Robotic Surgery for Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01591798
First received: March 16, 2012
Last updated: May 3, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Quality of mesorectal excision [ Time Frame: 7days after surgery (Pathologic report) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Sexual and urinary function, Quality of life, Anorectal function [ Time Frame: Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
    IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry

  • Long-term outcome [ Time Frame: Postoperative 36 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ji Won Park, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01591798     History of Changes
Other Study ID Numbers: NCC-CTS603
Study First Received: March 16, 2012
Last Updated: May 3, 2012
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014