Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.
This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic surgery | Experimental | Proctectomy using robot |
|
| Laparoscopic surgery | Active Comparator | Conventional laparoscopic rectal resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic surgery | Procedure | Robotic assisted rectal resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of mesorectal excision | Evaluating the quality of mesorectal excision in rectal specimen according to the criteria suggested by Nagtegaal ID, et al. (J Clin Oncol. 2002;20:1729-34) | 7days after surgery (Pathologic report) |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term postoperative outcome | Within postoperative 30 days | |
| Sexual and urinary function, Quality of life, Anorectal function | IIEF, FSFI, IPSS, EORTC C30, CR38, FISI, MSKCC bowel fuction tool, Manometry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hwan Oh, Dr. | Contact | 82-31-920-1637 | jayoh@ncc.re.kr | |
| Ji Won Park, Dr. | Contact | 82-31-920-1894 | sowisdom@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Ji Won Park, Dr. | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Laparoscopic surgery | Procedure | Laparoscopic assisted rectal resection |
|
| Baseline, postop 3 weeks, 3months, 12 months, 24 months, 36 months |
| Long-term outcome | 3 year disese-free survival | Postoperative 36 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |