An interventional study of gasless single-port laparoscopic surgery and conventional laparoscopic surgery in Laparoscopic Surgery, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-12.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery.
Procedure: gasless single-port laparoscopic surgery
radical resection of rectal carcinoma is performed by conventional laparoscopic surgery.
Procedure: conventional laparoscopic surgery
The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.
The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.
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.
Time frame: 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.
Time frame: Change from baseline CD4/CD8 ratio 7 days after operation.
Operation time
Measure the operation time, which will be compared with comparator.
Time frame: at 1 day
Postoperative pain
Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.
Time frame: 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.
Time frame: 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.
Time frame: at 1 week after operation
Plan to share: No
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The Second Affiliated Hospital of Chongqing Medical University