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The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.
The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSRCLM | Experimental | robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).Three different liver resection procedures were chose to personalized patients. Generally, when the size of liver metastasis was ≤ 3 cm, a wedge resection was chose without Hilar vessels blocking. The segmentectomy was performed using the Glissonian approach when tumor size was among 3-5 cm, and Hilar vessels was blocked, if necessary. For resection of Couinaud's segments II and III, left lateral sectionectomy (LLS) was performed commonly. Intraoperative ultrasound can help us find intrahepatic pedicles and follow the proper resection line. When liver tumor size was more than 5 cm or more than 3 tumors with the size over 3cm, hemicolectomy was applied usually. |
|
| Open | Active Comparator | Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSRCLM | Procedure | The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM). |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Complication | According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery | 30 days after surgury |
| Measure | Description | Time Frame |
|---|---|---|
| Operative mortality | death occurred 30 days after operation | 30 days post operatively |
| Disease-free survival(DFS) | DFS was defined as from the date of randomization to the date of tumor |
| Measure | Description | Time Frame |
|---|---|---|
| self reported bladder function | This section is assessed using a self-rating scale "International prostate symptom score" (IPSS) | at postoperative 3, 6 and 1 2 months |
| self reported sexual function for male patients |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianmin Xu, MD | Contact | 008613501984869 | xujmin@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| wenju chang, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Zhongshan Hospital, Fudan University | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37800563 | Derived | Chang W, Ye Q, Xu D, Liu Y, Zhou S, Ren L, He G, Zhou G, Liang F, Fan J, Wei Y, Wang X, Xu J. Robotic versus open surgery for simultaneous resection of rectal cancer and liver metastases: a randomized controlled trial. Int J Surg. 2023 Nov 1;109(11):3346-3353. doi: 10.1097/JS9.0000000000000581. |
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micro-invasive surgery
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|
| Open | Procedure | Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis |
|
| 3 years disease-free survival |
| overall survival (OS) | overall survival was defined as from the date of randomization to the date of Death ; | OS rate at 3 and 5 years after operation |
| locoregional recurrence rate | local recurrence rate at 3 and 5 years after operation | 3 and 5 years |
This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
| at postoperative 3, 6 and 1 2 month |
| self reported sexual function for female patients | This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI). | at postoperative 3, 6 and 1 2 months |
| liver function | Serum aminotransferase will be tested in the laboratory | at Day 1，3，5 after surgery |