Natural Orifice Specimen Extraction Surgery, Rectal Neoplasms, Robotic Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETransanal specimen extraction robotic surgery
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
PROCEDURETransabdominal specimen extraction robotic surgery
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.
Sponsors
Taiyuan Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 to 75 years; 2. Historically confirmed rectal adenocarcinoma; 3. Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging; 4. cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma; 5. No evidence of distant metastases; 6. A maximum of 5cm in diameter; 7. Body mass index (BMI) ≤ 30 kg / m2; 8. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion); 9. Willing to undergo surgery; 10. Sign the informed consent;
Exclusion criteria
1. Presence of lateral/inguinal lymph node metastases; 2. Previous history of malignant colorectal tumor; 3. Multiple primary colorectal tumors; 4. Neoadjuvant therapy; 5. Salvage surgery for endoscopic surgery; 6. History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion; 7. Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease; 8. Comorbid with other malignancies within 5 years; 9. ASA ≥ IV and/or ECOG performance status score ≥ 2; 10. Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases; 11. Serious mental illness; 12. Pregnant or lactating women; 13. Uncontrolled infection; 14. Abnormal anal function or anal stenosis;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Up to 30 days postoperatively. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin | 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks. | 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. |
| Cortisol | 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks. | Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function. |
| CD3, CD4, and CD8 lymphocyte subsets | 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks. | Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function. |
| Positive rate of tumor cells | Intraoperative. | 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. |
| bacterial positive rate | Intraoperative. | 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. |
| Pain assessment | 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks. | 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. |
| Wexner scale | 1 day before operation, and 1, 3, 6 months postoperatively. | Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function. |
| LARS scale | 1 day before operation, and 1, 3, 6 months postoperatively. | 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. |
| Postoperative recovery composite | Up to 2 weeks. | 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). |
| EORTC QLQ-C30 | 1 day before operation, 1, 3, 6 months postoperatively. | To assess the quality of life of all cancer patients. |
| EORTC QLQ-C38 | 1 day before operation, 1, 3, 6 months postoperatively. | To assess the quality of life in patients with rectal cancer. |
| C-reactive protein (CRP) | 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks. | Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function. |
| Number of Histopathological type | Up to 30 days postoperatively. | To assess the quality of surgical specimens and postoperative pathological evaluation. |
| Degree of differentiation | Up to 30 days postoperatively. | To assess the quality of surgical specimens and postoperative pathological evaluation. |
| Distance , positive condition of pathological margin (proximal, distal, circumferential) | Up to 30 days postoperatively. | To assess the quality of surgical specimens and postoperative pathological evaluation. |
| Number of lymph node dissection and metastasis | Up to 30 days postoperatively. | To assess the quality of surgical specimens and postoperative pathological evaluation. |
| Nerve vessel involvement rate | Up to 30 days postoperatively. | To assess the quality of surgical specimens and postoperative pathological evaluation. |
| Hospitalization costs | Up to 30 days. | To assess the financial burden difference. |
| Local recurrence rate | 1, 3, 5 years postoperatively. | To assess the long-term postoperative outcomes. |
| The incidence rate of distant metastasis | 1, 3, 5 years postoperatively. | To assess the long-term postoperative outcomes. |
| Tumor-free survival rates | 1, 3, 5 years postoperatively. | To assess the long-term postoperative outcomes. |
| Overall survival rate | 1, 3, 5 years postoperatively. | To assess the long-term postoperative outcomes. |
| Tumor size | Up to 30 days postoperatively. | To assess the quality of surgical specimens. |
Countries
China
Outcome results
None listed