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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05468944
Other study ID # RO220624
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2023
Est. completion date December 2025

Study information

Verified date July 2022
Source The First Affiliated Hospital of Nanchang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 556
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transanal specimen extraction robotic surgery
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Transabdominal 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.

Locations

Country Name City State
China 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 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 Zhongshan Hospital of Xiamen University Xiamen
China The First Affiliated Hospital of Zhengzhou University Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Taiyuan Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 30 days postoperatively.
Secondary C-reactive protein (CRP) Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function. 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary 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. 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary Cortisol Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function. 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary CD3, CD4, and CD8 lymphocyte subsets Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function. 1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary 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. Intraoperative.
Secondary 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. Intraoperative.
Secondary 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. 1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
Secondary 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. 1 day before operation, and 1, 3, 6 months postoperatively.
Secondary 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. 1 day before operation, and 1, 3, 6 months postoperatively.
Secondary 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). Up to 2 weeks.
Secondary EORTC QLQ-C30 To assess the quality of life of all cancer patients. 1 day before operation, 1, 3, 6 months postoperatively.
Secondary EORTC QLQ-C38 To assess the quality of life in patients with rectal cancer. 1 day before operation, 1, 3, 6 months postoperatively.
Secondary Tumor size To assess the quality of surgical specimens. Up to 30 days postoperatively.
Secondary Number of Histopathological type To assess the quality of surgical specimens and postoperative pathological evaluation. Up to 30 days postoperatively.
Secondary Degree of differentiation To assess the quality of surgical specimens and postoperative pathological evaluation. Up to 30 days postoperatively.
Secondary Distance , positive condition of pathological margin (proximal, distal, circumferential) To assess the quality of surgical specimens and postoperative pathological evaluation. Up to 30 days postoperatively.
Secondary Number of lymph node dissection and metastasis To assess the quality of surgical specimens and postoperative pathological evaluation. Up to 30 days postoperatively.
Secondary Nerve vessel involvement rate To assess the quality of surgical specimens and postoperative pathological evaluation. Up to 30 days postoperatively.
Secondary Hospitalization costs To assess the financial burden difference. Up to 30 days.
Secondary Local recurrence rate To assess the long-term postoperative outcomes. 1, 3, 5 years postoperatively.
Secondary The incidence rate of distant metastasis To assess the long-term postoperative outcomes. 1, 3, 5 years postoperatively.
Secondary Tumor-free survival rates To assess the long-term postoperative outcomes. 1, 3, 5 years postoperatively.
Secondary Overall survival rate To assess the long-term postoperative outcomes. 1, 3, 5 years postoperatively.
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