Clinical trial NCT05468944: Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
Official title: Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Robotic Surgery
Natural Orifice Specimen Extraction Surgery
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Complication rate
timeFrame: Up to 30 days postoperatively.
Secondary outcomes:
measure: C-reactive protein (CRP)
timeFrame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
measure: Interleukin
timeFrame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
measure: Cortisol
timeFrame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
measure: CD3, CD4, and CD8 lymphocyte subsets
timeFrame: 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
measure: Positive rate of tumor cells
timeFrame: Intraoperative.
measure: bacterial positive rate
timeFrame: Intraoperative.
measure: Pain assessment
timeFrame: 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
measure: Wexner scale
timeFrame: 1 day before operation, and 1, 3, 6 months postoperatively.
measure: LARS scale
timeFrame: 1 day before operation, and 1, 3, 6 months postoperatively.
measure: Postoperative recovery composite
timeFrame: Up to 2 weeks.
measure: EORTC QLQ-C30
timeFrame: 1 day before operation, 1, 3, 6 months postoperatively.
measure: EORTC QLQ-C38
timeFrame: 1 day before operation, 1, 3, 6 months postoperatively.
measure: Tumor size
timeFrame: Up to 30 days postoperatively.
measure: Number of Histopathological type
timeFrame: Up to 30 days postoperatively.
measure: Degree of differentiation
timeFrame: Up to 30 days postoperatively.
measure: Distance , positive condition of pathological margin (proximal, distal, circumferential)
timeFrame: Up to 30 days postoperatively.
measure: Number of lymph node dissection and metastasis
timeFrame: Up to 30 days postoperatively.
measure: Nerve vessel involvement rate
timeFrame: Up to 30 days postoperatively.
measure: Hospitalization costs
timeFrame: Up to 30 days.
measure: Local recurrence rate
timeFrame: 1, 3, 5 years postoperatively.
measure: The incidence rate of distant metastasis
timeFrame: 1, 3, 5 years postoperatively.
measure: Tumor-free survival rates
timeFrame: 1, 3, 5 years postoperatively.
measure: Overall survival rate
timeFrame: 1, 3, 5 years postoperatively.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
city: Chongqing
country: China
facility: Three Gorges Hospital Affiliated to Chongqing University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Ganzhou
country: China
facility: The First Affiliated Hospital of Gannan Medical University
city: Guangzhou
country: China
facility: The Second Affiliated Hospital, Sun Yat-sen University
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: Zhongshan Hospital of Xiamen University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: