Laparoscopic Surgery
Conditions
Keywords
gasless single-port laparoscopic surgery;rectal carcinoma
Brief summary
This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.
Detailed description
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.
Interventions
PROCEDUREgasless single-port laparoscopic surgery
The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.
PROCEDUREconventional laparoscopic surgery
The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.
Exclusion criteria
* Neoadjuvant therapy;Surgical contraindication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over. | 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. |
| Immunologic function | Change from baseline CD4/CD8 ratio 7 days after operation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | at 1 day | Measure the operation time, which will be compared with comparator. |
| Postoperative pain | 72 hours after operation | Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator. |
| Bowel function | up to 1 week after operation | Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus. |
| Number of the lymph node dissection | at 1 week after operation | Measure the number of the regional lymph node dissection after operation, which will be compared with comparator. |
Countries
China
Contacts
Primary ContactJijian Wang, phD
Backup ContactJianbo Zhang, phD
Outcome results
None listed