Rectal Cancer, Surgery
Conditions
Keywords
Rectal Cancer, Robotic Surgery
Brief summary
This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
Detailed description
Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. Most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. However, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer，especially in rectal cancer surgery. The purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
Interventions
PROCEDURESingle-port robotic surgery
In this group, patients will be operated using a single-port surgical robot system. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. The surgical procedure followed the principle of total mesorectal excision.
PROCEDUREMulti-port robotic surgery
In this group, patients will be operated using a multi-port surgical robot system. Surgical instruments enter the abdominal cavity through 4 separate trocars. The surgical procedure followed the principle of total mesorectal excision.
Sponsors
Shandong Provincial Hospital
First Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Henan University of Science and Technology
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 years \< age ≤80 years * Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge) * Pathological rectal carcinoma * Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual * Tumor size of 10 cm or less * No history of other malignant tumors * ECOG score is 0-1 * ASA score is Ⅰ-Ⅲ * Informed consent
Exclusion criteria
* Body mass index (BMI) \>35 kg/m2 * Familial adenomatous polyposis (FAP) * Inflammatory bowel disease (IBD) * Multiple malignant colorectal tumors * Pregnant woman or lactating woman * Severe mental disease * Previous gastrointestinal surgery (except appendectomy ） * Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery * Requirement of simultaneous surgery for other disease * Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery. * Patients or family members who cannot understand the study program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success rate | intraoperative | Proportion of robotic procedures not converted to laparoscopic or open surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | intraoperative | Estimated blood loss（milliliters，ml） |
| Incision length | intraoperative | Incision length（centimeters，cm） |
| Total incision length | intraoperative | The sum of all incision lengths（centimeters，cm） |
| Length of stay | 1-30 days after surgery | The postoperative day when patients complied with the predefined discharge |
| Postoperative recovery course | 1-14 days after surgery | Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery） |
| Early morbidity rate | 30 days after surgery | morbidity rate 30 days after surgery |
| Operative time | intraoperative | Operative time（minutes） |
| Tumor size | 14 days after surgery | The diameter of tumors（centimeters，cm） |
| Incisal margin | 14 days after surgery | Length of proximal and distal margin （centimeters，cm） |
| Lymph node detection | 14 days after surgery | Lymph nodes harvested（numbers） |
| Cosmetic effect | 1 month, 6 months and 1 year after surgery | European Organization for Research and Treatment of Cancer Quality of Life |
| The quality of life-Colorectal | 1 month, 6 months and 1 year after surgery | European Organization for Research and Treatment of Cancer Quality of Life |
| disease free survival rate | 12 months after surgery | 1-year disease free survival rate |
| Pain score | 1-3 days after surgery | postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 |
Countries
China
Contacts
Primary ContactRen Zhao, MD, PHD
Backup ContactKun Liu, MD
Outcome results
None listed