This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
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.
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.
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Surgical success rate
Proportion of robotic procedures not converted to laparoscopic or open surgery
Time frame: intraoperative
Operative time
Operative time(minutes)
Time frame: intraoperative
Intraoperative blood loss
Estimated blood loss(milliliters,ml)
Time frame: intraoperative
Incision length
Incision length(centimeters,cm)
Time frame: intraoperative
Total incision length
The sum of all incision lengths(centimeters,cm)
Time frame: intraoperative
Length of stay
The postoperative day when patients complied with the predefined discharge
Time frame: 1-30 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and semi-liquid diet (hours after surgery)
Time frame: 1-14 days after surgery
Early morbidity rate
morbidity rate 30 days after surgery
Time frame: 30 days after surgery
Pain score
postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3
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Time frame: 1-3 days after surgery
Tumor size
The diameter of tumors(centimeters,cm)
Time frame: 14 days after surgery
Incisal margin
Length of proximal and distal margin (centimeters,cm)
Time frame: 14 days after surgery
Lymph node detection
Lymph nodes harvested(numbers)
Time frame: 14 days after surgery
Cosmetic effect
European Organization for Research and Treatment of Cancer Quality of Life
Time frame: 1 month, 6 months and 1 year after surgery
The quality of life-Colorectal
European Organization for Research and Treatment of Cancer Quality of Life
Time frame: 1 month, 6 months and 1 year after surgery
disease free survival rate
1-year disease free survival rate
Time frame: 12 months after surgery