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This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.
The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gasless single-port laparoscopic surgery | Experimental | radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery. |
|
| conventional laparoscopic surgery | Sham Comparator | radical resection of rectal carcinoma is performed by conventional laparoscopic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gasless single-port laparoscopic surgery | Procedure | The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function | Estimate the pulmonary function in the perioperational period by blood gas analysis, which will be compared with comparator.The main parameter partial pressure of oxygen(PaO2)/inspired oxygen fraction(FiO2) ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen. | Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over. |
| Immunologic function | Estimate the immunologic function in the perioperational period by blood lymphocyte analysis, which will be compared with comparator.The main parameter cluster of differentiation 4(CD4)/cluster of differentiation 8(CD8) ratio is the ratio of lymphocyte CD4 numbers to lymphocyte CD8 numbers. | Change from baseline CD4/CD8 ratio 7 days after operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Measure the operation time, which will be compared with comparator. | at 1 day |
| Postoperative pain | Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jijian Wang, phD | Contact | 02363693511 | wangjj1963@163.com | |
| Jianbo Zhang, phD | Contact | 02363693510 | 172329491@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jijian Wang, phD | The Second Affiliated Hospital of Chongqing Medical University | Study Chair |
| Yaxu Wang, phD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
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| conventional laparoscopic surgery | Procedure | The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room. |
|
| 72 hours after operation |
| Bowel function | Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus. | up to 1 week after operation |
| Number of the lymph node dissection | Measure the number of the regional lymph node dissection after operation, which will be compared with comparator. | at 1 week after operation |
| Yang Li, phD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Daihua Zhu, phD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Jianbo Zhang, phD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Haitao Gu, phD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Shiji Zhou, phD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Zhiquan Xu, Bachelor | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |