Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer (COLRAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Kyungpook National University
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01423214
First received: August 1, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

This study sets up the final study end point and three detailed goals as the following.

The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low rectum.

Detailed goal of study:

The primary endpoint: This study is designed to assess whether robotic surgical system improves the quality of rectal cancer surgery, especially in total mesorectal excision quality and a circumferential margin positivity rate

The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and overall survival after robot and laparoscopic resection of distal rectal cancer. This study will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological quality (i.e. number of harvested lymph node), local recurrence, and blood loss during surgery.


Condition Intervention Phase
Rectal Cancer
Procedure: robot-assisted surgery
Procedure: Laparoscopic surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Surgical quality based on pathological examination [ Time Frame: up to 4 weeks after operation ] [ Designated as safety issue: No ]
    A comparison of completeness of total mesorectal excision


Secondary Outcome Measures:
  • Postoperative morbidity [ Time Frame: up to 30 dyas after operation ] [ Designated as safety issue: Yes ]
    A comparison of the postoperative recovery variables, the postoperative complications and mortality

  • Pelvic autonomic nerve preservation (intraoperative confirmation of pelvic nerve preservation) [ Time Frame: The day of operation ] [ Designated as safety issue: Yes ]
    During procedure, a surgeon indentifies pelvic autonomic nerve and confirm whether the nerves are preserved or sacrificed.

  • Change from Baseline in QLQ 30, IIEF-5(5-item Version of the International Index of Erectile Function), IPSS(International Prostate Symptom Score), FSFI(Female Sexual Function Index), and Wexner's scoring [ Time Frame: up to 12months after operation ] [ Designated as safety issue: No ]
    EORTC QLQ 30:an assessment tool for measuring the quality of life IIEF-5 : an assessment tool for measuring male erectile function IPSS : an assessment tool for measuring voiding function FSFI : an assessment tool for measuring female sexual function Wexner's scoring : an assessment tool for measuring anal sphincter function Time points : 1,3,6, and 12months after operation

  • 5-year overall survival rate [ Time Frame: up to 5 yearsa after operation ] [ Designated as safety issue: No ]
    A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.

  • 5-year disease-free survival rate [ Time Frame: up to 5 years after operation ] [ Designated as safety issue: No ]
    A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.


Estimated Enrollment: 540
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic LAR
Individuals who underwent robot-assisted surgery for primary rectal cancer
Procedure: robot-assisted surgery
da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
Active Comparator: Lap LAR
Individuals who underwent laparoscopic surgery for primary rectal cancer
Procedure: Laparoscopic surgery
Conventional laparoscopic procedures

Detailed Description:

Recently, the efficacy and oncological safety of laparoscopy has been demonstrated for treating colon cancer, and similar long-term results at 5-year confirmed by the several multicenter study trial. However, conventional laparoscopic surgery for rectal cancer is technically more difficult than colonic resection because of the confined space in the pelvis and the limitations of existing laparoscopic instruments which have a restricted range of movement compared with the provided by the surgeon's hand. Consequently, recent studies which compared short-term outcomes between open and laparoscopic rectal resections have reported higher rates of conversion to open surgery, positive circumferential margins, and increased anastomotic leakage in patients who underwent laparoscopic approach.

The da Vinci® Surgical System (Intuitive surgical, Sunnyvale, CA, USA) was introduced as the next advance in minimally invasive surgery to overcome the technical limitations of laparoscopy. The advantages of robotic assistance include enhanced dexterity, improved three-dimensional vision, and more intuitive instrument manipulation. This device eases the technical challenges of the minimally invasive approach and may make a complex surgical task more accessible to surgeons without extensive laparoscopic experience.

With its dependence on precise dissection in a narrow pelvic cavity, it is anticipated that rectal cancer surgery is one of the indications most likely to benefit from robot assistance. However, it is difficult to conclude whether robot assistance leads to better outcomes because few studies have directly compared the three existing techniques. Although robotic rectal excision has been reported to be safe and feasible in the recent literatures, a number of these results were based on small number of case series. There have been no randomized trials demonstrating the safety of robotic surgery in the treatment of rectal cancer. This study is designed to assess the efficacy and safety of robotic surgery compared with that of laparoscopic surgery for mid or low rectal cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligibility rule of enrollment
  • Rectal adenocarcinoma that were 10 cm or less from the anal verge
  • at least 18 years old & at most 80 years old
  • Clinically diagnosed cT3N0-2 disease
  • Clinical diagnosis of carcinoma involving a single rectal segment
  • Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography

Exclusion Criteria:

  • The presence of metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, lateral pelvic wall lymph node and inguinal lymph node
  • A past history of the cancer occurring in other body areas than the rectal cancer (except for a past history of the radical resection due to skin cancer)
  • Severe cardiac diseases or failure
  • Severe pulmonary diseases or dysfunction
  • The presence of psychiatric diseases
  • The concurrent presence of other severe medical diseases
  • An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
  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: NCT01423214

Contacts
Contact: Gyu-Seog Choi, M.D. +82-53-200-2166 kyuschoi@mail.knu.ac.kr
Contact: Jun seok Park, M.D. +82-53-200-2166 caumed5@naver.com

Locations
Korea, Republic of
Gyu seog Choi Recruiting
Daegu, Korea, Republic of, 702-210
Contact: Jun seok Park, M.D.    +82-53-200-2166    caumed5@naver.com   
Nam Kyu Kim Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Byung Soh Min, M.D.       bsmin@yuhs.ac   
Seon-Hahn Kim Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Sae Jin Baek, D.M.       xezin@korea.ac.kr   
Sponsors and Collaborators
Kyungpook National University
Investigators
Study Chair: Gyu seog Choi, M.D Kyunpook National Univercity Medical Center
  More Information

No publications provided

Responsible Party: Gyu-Seog Choi, Colorectal Cancer Center, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01423214     History of Changes
Other Study ID Numbers: KNUHCRC003
Study First Received: August 1, 2011
Last Updated: July 11, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
rectal cancer
robot
laparoscopy
total mesorectal excision
robotic 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