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

Rectal Cancer Clinical Trial

— COLRAR  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01423214
• Other study ID #: KNUHCRC003
• Status: Recruiting
• Phase: Phase 3
• First received: August 1, 2011
• Last updated: March 9, 2015
• Start date: June 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2015
• Source: Kyungpook National University
• Contact: Gyu-Seog Choi, M.D.
• Phone: +82-53-200-2166
• Email: kyuschoi[@]mail.knu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• robot-assisted surgery
da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
• Laparoscopic surgery
Conventional laparoscopic procedures

Locations

Country	Name	City	State
Korea, Republic of	Gyu seog Choi	Daegu
Korea, Republic of	Nam Kyu Kim	Seoul
Korea, Republic of	Seon-Hahn Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical quality based on pathological examination	A comparison of completeness of total mesorectal excision	up to 4 weeks after operation	No
Secondary	Postoperative morbidity	A comparison of the postoperative recovery variables, the postoperative complications and mortality	up to 30 dyas after operation	Yes
Secondary	Pelvic autonomic nerve preservation (intraoperative confirmation of pelvic nerve preservation)	During procedure, a surgeon indentifies pelvic autonomic nerve and confirm whether the nerves are preserved or sacrificed.	The day of operation	Yes
Secondary	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	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	up to 12months after operation	No
Secondary	5-year overall survival rate	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.	up to 5 yearsa after operation	No
Secondary	5-year disease-free survival rate	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.	up to 5 years after operation	No