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

NCT01423214 | Unknown Phase 3 DMC

• 1 other identifier: KNUHCRC003
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 3

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; robot; laparoscopy; total mesorectal excision; robotic surgery

Outcome Measures

Primary Outcomes (1)

• Surgical quality based on pathological examination

  A comparison of completeness of total mesorectal excision

  up to 4 weeks after operation

Secondary Outcomes (5)

• Postoperative morbidity

  up to 30 dyas after operation

• Pelvic autonomic nerve preservation (intraoperative confirmation of pelvic nerve preservation)

  The day of operation

• 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

  up to 12months after operation

• 5-year overall survival rate

  up to 5 yearsa after operation

• 5-year disease-free survival rate

  up to 5 years after operation

Study Arms (2)

Robotic LAR

EXPERIMENTAL

Individuals who underwent robot-assisted surgery for primary rectal cancer

Procedure: robot-assisted surgery

Lap LAR

ACTIVE COMPARATOR

Individuals who underwent laparoscopic surgery for primary rectal cancer

Procedure: Laparoscopic surgery

Interventions

robot-assisted surgery PROCEDURE

da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)

Robotic LAR

Laparoscopic surgery PROCEDURE

Conventional laparoscopic procedures

Lap LAR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (3)

Gyu seog Choi

Daegu, 702-210, South Korea

RECRUITING

Nam Kyu Kim

Seoul, 120-752, South Korea

NOT YET RECRUITING

Seon-Hahn Kim

Seoul, 136-705, South Korea

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Robotic Surgical Procedures; Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Gyu seog Choi, M.D

  Kyunpook National Univercity Medical Center

  STUDY CHAIR

Central Study Contacts

Gyu-Seog Choi, M.D.

CONTACT

+82-53-200-2166; kyuschoi@mail.knu.ac.kr

Jun seok Park, M.D.

CONTACT

+82-53-200-2166; caumed5@naver.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Cancer Center

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 25, 2011
• Study Start: June 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

KR (3)