Efficacy Study of Robotic Surgery for Rectal Cancer

May 3, 2012 updated by: Ji Won Park, National Cancer Center, Korea

Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae Hwan Oh, Dr.
  • Phone Number: 82-31-920-1637
  • Email: jayoh@ncc.re.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic surgery
Proctectomy using robot
Procedure: Robotic surgery
Robotic assisted rectal resection
Other Names:
  • da Vinci Surgical System
Active Comparator: Laparoscopic surgery
Conventional laparoscopic rectal resection
Procedure: Laparoscopic surgery
Laparoscopic assisted rectal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7days after surgery (Pathologic report)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term postoperative outcome
Time Frame: Within postoperative 30 days
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
Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months
Long-term outcome
Time Frame: Postoperative 36 months
3 year disese-free survival
Postoperative 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 3, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-CTS603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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