This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.
In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
556
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
The Second Xiangya Hospital, Central South University
Changsha, China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, China
Complication rate
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
Time frame: Up to 30 days postoperatively.
C-reactive protein (CRP)
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Interleukin
Detection of serum levels of Interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10) (pg/L) to evaluate surgical stress response and immune function.
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Cortisol
Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
CD3, CD4, and CD8 lymphocyte subsets
Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.
Time frame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Positive rate of tumor cells
Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.
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Fujian Cancer Hospital
Fuzhou, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, China
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Zhongshan Hospital, Fudan University
Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
...and 2 more locations
Time frame: Intraoperative.
bacterial positive rate
Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.
Time frame: Intraoperative.
Pain assessment
Visual analogue scale (VAS) will be used to evaluate the postoperative pain. If analgesics were needed, the type and dose of analgesics after operation should be recorded.
Time frame: 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
Wexner scale
Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.
Time frame: 1 day before operation, and 1, 3, 6 months postoperatively.
LARS scale
LARS scale(0\~20 points are defined as no LARS, Scores from 21 to 29 were defined as mild LARS, and from 30 to 42 as severe LARS. The higher the score, the worse the anal bowel function) will be used to evaluate the defecation function.
Time frame: 1 day before operation, and 1, 3, 6 months postoperatively.
Postoperative recovery composite
Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours, and perform auscultation of bowel sounds regularly every day after operation), the time to first ambulation (hours), the time to first eating (hours) and the time to first defecation (hours).
Time frame: Up to 2 weeks.
EORTC QLQ-C30
To assess the quality of life of all cancer patients.
Time frame: 1 day before operation, 1, 3, 6 months postoperatively.
EORTC QLQ-C38
To assess the quality of life in patients with rectal cancer.
Time frame: 1 day before operation, 1, 3, 6 months postoperatively.
Tumor size
To assess the quality of surgical specimens.
Time frame: Up to 30 days postoperatively.
Number of Histopathological type
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time frame: Up to 30 days postoperatively.
Degree of differentiation
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time frame: Up to 30 days postoperatively.
Distance , positive condition of pathological margin (proximal, distal, circumferential)
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time frame: Up to 30 days postoperatively.
Number of lymph node dissection and metastasis
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time frame: Up to 30 days postoperatively.
Nerve vessel involvement rate
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time frame: Up to 30 days postoperatively.
Hospitalization costs
To assess the financial burden difference.
Time frame: Up to 30 days.
Local recurrence rate
To assess the long-term postoperative outcomes.
Time frame: 1, 3, 5 years postoperatively.
The incidence rate of distant metastasis
To assess the long-term postoperative outcomes.
Time frame: 1, 3, 5 years postoperatively.
Tumor-free survival rates
To assess the long-term postoperative outcomes.
Time frame: 1, 3, 5 years postoperatively.
Overall survival rate
To assess the long-term postoperative outcomes.
Time frame: 1, 3, 5 years postoperatively.