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Phase 3
18 Years
80 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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 VinciĀ® 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Surgical quality based on pathological examination

Outcome Description:

A comparison of completeness of total mesorectal excision

Outcome Time Frame:

up to 4 weeks after operation

Safety Issue:


Principal Investigator

Gyu seog Choi, M.D

Investigator Role:

Study Chair

Investigator Affiliation:

Kyunpook National Univercity Medical Center


South Korea: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

December 2018

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • robot
  • laparoscopy
  • total mesorectal excision
  • robotic surgery
  • Rectal Neoplasms