Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer With Liver Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02642978|
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Liver Metastasis||Procedure: RSRCLM Procedure: Open||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||micro-invasive surgery|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study|
|Actual Study Start Date :||September 1, 2015|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
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.
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).
Active Comparator: Open
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis
- Surgical Complication [ Time Frame: 30 days after surgury ]According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery
- Operative mortality [ Time Frame: 30 days post operatively ]death occurred 30 days after operation
- Disease-free survival(DFS) [ Time Frame: 3 years disease-free survival ]DFS was defined as from the date of randomization to the date of tumor
- overall survival (OS) [ Time Frame: OS rate at 3 and 5 years after operation ]overall survival was defined as from the date of randomization to the date of Death ;
- locoregional recurrence rate [ Time Frame: 3 and 5 years ]local recurrence rate at 3 and 5 years after operation
- self reported bladder function [ Time Frame: at postoperative 3, 6 and 1 2 months ]This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)
- self reported sexual function for male patients [ Time Frame: at postoperative 3, 6 and 1 2 month ]This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
- self reported sexual function for female patients [ Time Frame: at postoperative 3, 6 and 1 2 months ]This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).
- liver function [ Time Frame: at Day 1，3，5 after surgery ]Serum aminotransferase will be tested in the laboratory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642978
|Contact: jianmin Xu, MDfirstname.lastname@example.org|
|Department of General Surgery, Zhongshan Hospital, Fudan University||Recruiting|
|Shanghai, China, 200032|
|Contact: jianmin xu, professor 008613501984869 email@example.com|
|Contact: yunshi zhong, doctor 008613564623481 firstname.lastname@example.org|
|Principal Investigator:||wenju chang, MD||Fudan University|