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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01423214
Recruitment Status : Recruiting
First Posted : August 25, 2011
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University

Brief Summary:

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 or disease Intervention/treatment Phase
Rectal Cancer Procedure: robot-assisted surgery Procedure: Laparoscopic surgery Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Surgical quality based on pathological examination [ Time Frame: up to 4 weeks after operation ]
    A comparison of completeness of total mesorectal excision

Secondary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: up to 30 dyas after operation ]
    A comparison of the postoperative recovery variables, the postoperative complications and mortality

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

  3. 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 ]
    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

  4. 5-year overall survival rate [ Time Frame: up to 5 yearsa after operation ]
    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. 5-year disease-free survival rate [ Time Frame: up to 5 years after operation ]
    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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01423214

Contact: Gyu-Seog Choi, M.D. +82-53-200-2166
Contact: Jun seok Park, M.D. +82-53-200-2166

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

Responsible Party: Gyu-Seog Choi, Colorectal Cancer Center, Kyungpook National University Identifier: NCT01423214     History of Changes
Other Study ID Numbers: KNUHCRC003
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Gyu-Seog Choi, Kyungpook National University:
rectal cancer
total mesorectal excision
robotic 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