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In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
Based on investigators' experience, compared to robotic-assisted colorectal cancer radical resection, robotic colorectal cancer radical resection with natural orifice extraction has more advantages in postoperative stress response, postoperative pain, postoperative recovery and postoperative abdominal aesthetics. However, in terms of tumor radicality, there may be no obvious differences. There are no randomized controlled trails to discuss these questions.This research is based on the above conditions. Investigators use prospective randomized controlled trial to analyze the surgical data, postoperative complications, postoperative recovery of the robotic colorectal cancer radical resection with natural orifice extraction and conventional robotic-assisted colorectal cancer radical resection in order to summarize clinical experience and explore the advantages and disadvantages of robotic colorectal cancer radical resection with natural orifice specimen extraction and to provide a new direction for the surgical treatment of colorectal cancer, which is beneficial to the promotion of NOSES(Natural Orifice Specimen Extraction Surgery ) technology and treatment of colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Orifice Specimen Extraction Surgery | Experimental | Natural orifice specimen extraction surgery will performed in patients assigned to this group. |
|
| Traditional Robotic-assisted Surgery | Active Comparator | Traditional robotic-assisted surgery will performed in patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Orifice Specimen Extraction Surgery | Procedure | In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgical complications | Complication rate of surgery within 30 days after surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The variation of C-reactive protein | The values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response. | Preoperative 3 days and postoperative 1, 3, and 7 days |
| The variation of interleukin-6(IL-6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taiyuan Li, M.D., Ph.D | Contact | +86-13970031518 | jylitaiyuan@sina.com | |
| Dongning Liu, M.D., Ph.D | Contact | +86-13576982921 | liudongning1982@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Taiyuan Li, M.D., Ph.D | Department of General Surgery, The First Affiliated Hospital of Nanchang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital (301 Hospital) China | Recruiting | Beijing | Beijing Municipality | 100036 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33549133 | Derived | Luo R, Zheng F, Zhang H, Zhu W, He P, Liu D. Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial. Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z. |
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| Traditional Robotic-assisted Surgery | Procedure | In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection. |
|
The values of interleukin-6(IL-6) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response. |
| Preoperative 3 days and postoperative 1, 3, and 7 days |
| The variation of interleukin-10(IL-10) | The values of interleukin-10(IL-10) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response. | Preoperative 3 days and postoperative 1, 3, and 7 days |
| The variation of cortisol | The values of cortisol from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response. | Preoperative 3 days and postoperative 1, 3, and 7 days |
| The variation of lymphocyte subsets count of CD3, CD4 and CD8 | The values of lymphocyte subsets count of CD3, CD4 and CD8 from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response. | Preoperative 3 days and postoperative 1, 3, and 7 days |
| The positive rate of malignant cells in ascitic fluid specimen | Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory. | 1 day |
| The positive rate of bacterial culture in ascitic fluid specimen | Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory. | 1 day |
| Postoperative pain score | Postoperative pain score will be assessed by visual analog score. | 1 day |
| Time to first flatus | Time to first flatus is used to assess the postoperative recovery course | 30 days |
| Time to leave bed postoperatively | Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course. | 30 days |
| Time to first liquid diet postoperatively | Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course. | 30 days |
| Postoperative hospital stay | Postoperative hospital stay is used to assess the postoperative recovery course. | 30 days |
| Operation time | Time from start of incision to finish of abdominal closure. | 1 day |
| Estimated blood loss | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. | 1 day |
| Number of retrieved lymph nodes | Number of retrieved lymph nodes will be determined according to the pathological report. | 1 day |
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
|
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | China |
|
| First Affiliated Hospital of Gannan Medical College | Recruiting | Ganzhou | Jiangxi | 341 000 | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 360006 | China |
|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 360006 | China |
|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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