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Efficacy Study of Robotic Surgery for Rectal Cancer

Primary Purpose

Rectal Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robotic surgery
Laparoscopic surgery
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasm focused on measuring Rectal cancer, Robotic surgery, Laparoscopic surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic surgery

Laparoscopic surgery

Arm Description

Proctectomy using robot

Conventional laparoscopic rectal resection

Outcomes

Primary Outcome Measures

Quality of mesorectal excision
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
Sexual and urinary function, Quality of life, Anorectal function
IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry
Long-term outcome
3 year disese-free survival

Full Information

First Posted
March 16, 2012
Last Updated
May 3, 2012
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01591798
Brief Title
Efficacy Study of Robotic Surgery for Rectal Cancer
Official Title
Clinical Assessment of Laparoscopic and Robotic Surgery for Rectal Cancer - Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasm
Keywords
Rectal cancer, Robotic surgery, Laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic surgery
Arm Type
Experimental
Arm Description
Proctectomy using robot
Arm Title
Laparoscopic surgery
Arm Type
Active Comparator
Arm Description
Conventional laparoscopic rectal resection
Intervention Type
Procedure
Intervention Name(s)
Robotic surgery
Other Intervention Name(s)
da Vinci Surgical System
Intervention Description
Robotic assisted rectal resection
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic surgery
Intervention Description
Laparoscopic assisted rectal resection
Primary Outcome Measure Information:
Title
Quality of mesorectal excision
Description
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)
Time Frame
7days after surgery (Pathologic report)
Secondary Outcome Measure Information:
Title
Short-term postoperative outcome
Time Frame
Within postoperative 30 days
Title
Sexual and urinary function, Quality of life, Anorectal function
Description
IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry
Time Frame
Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months
Title
Long-term outcome
Description
3 year disese-free survival
Time Frame
Postoperative 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hwan Oh, Dr.
Phone
82-31-920-1637
Email
jayoh@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Won Park, Dr.
Phone
82-31-920-1894
Email
sowisdom@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Won Park, Dr.
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hwan Oh, Dr.
Phone
82-31-920-1637
Email
jayoh@ncc.re.kr

12. IPD Sharing Statement

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Efficacy Study of Robotic Surgery for Rectal Cancer

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