Trials / Unknown
UnknownNCT02817126
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,240 (actual)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.
Detailed description
Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of robotic surgery for rectal cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Robot-assisted resection | Arm I: Robot-assisted resection using da vinci system. |
| PROCEDURE | Laparoscopic resection | Arm II: Traditional laparoscopic resection. |
Timeline
- Start date
- 2016-07-10
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2016-06-29
- Last updated
- 2022-03-22
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02817126. Inclusion in this directory is not an endorsement.