Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

• ClinicalTrials.gov Identifier: NCT05468944
• Recruitment Status: Not yet recruiting
• First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Sponsor: Taiyuan Li
• Information provided by (Responsible Party): Taiyuan Li, The First Affiliated Hospital of Nanchang University

Tracking Information

• First Submitted Date: July 13, 2022
• First Posted Date: July 21, 2022
• Last Update Posted Date: July 21, 2022
• Estimated Study Start Date: January 2023
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2022)

Complication rate [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 20, 2022)

• C-reactive protein (CRP) [ Time Frame: 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.
• Interleukin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 day before operation, 1, 3, 6 months postoperatively. ]
  To assess the quality of life of all cancer patients.
• EORTC QLQ-C38 [ Time Frame: 1 day before operation, 1, 3, 6 months postoperatively. ]
  To assess the quality of life in patients with rectal cancer.
• Tumor size [ Time Frame: Up to 30 days postoperatively. ]
  To assess the quality of surgical specimens.
• Number of Histopathological type [ Time Frame: Up to 30 days postoperatively. ]
  To assess the quality of surgical specimens and postoperative pathological evaluation.
• Degree of differentiation [ Time Frame: 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) [ Time Frame: Up to 30 days postoperatively. ]
  To assess the quality of surgical specimens and postoperative pathological evaluation.
• Number of lymph node dissection and metastasis [ Time Frame: Up to 30 days postoperatively. ]
  To assess the quality of surgical specimens and postoperative pathological evaluation.
• Nerve vessel involvement rate [ Time Frame: Up to 30 days postoperatively. ]
  To assess the quality of surgical specimens and postoperative pathological evaluation.
• Hospitalization costs [ Time Frame: Up to 30 days. ]
  To assess the financial burden difference.
• Local recurrence rate [ Time Frame: 1, 3, 5 years postoperatively. ]
  To assess the long-term postoperative outcomes.
• The incidence rate of distant metastasis [ Time Frame: 1, 3, 5 years postoperatively. ]
  To assess the long-term postoperative outcomes.
• Tumor-free survival rates [ Time Frame: 1, 3, 5 years postoperatively. ]
  To assess the long-term postoperative outcomes.
• Overall survival rate [ Time Frame: 1, 3, 5 years postoperatively. ]
  To assess the long-term postoperative outcomes.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Rectal Neoplasms
• Robotic Surgery
• Natural Orifice Specimen Extraction Surgery

Intervention

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

Study Arms

• Experimental: Transanal group
  Participants in this group underwent robotic surgery with transanal specimen extraction
  Intervention: Procedure: Transanal specimen extraction robotic surgery
• Active Comparator: Transabdominal group
  Participants in this group underwent robotic surgery with transabdominal specimen extraction
  Intervention: Procedure: Transabdominal specimen extraction robotic surgery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 20, 2022): 556
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05468944
• Other Study ID Numbers: RO220624
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taiyuan Li, The First Affiliated Hospital of Nanchang University
• Original Responsible Party: Same as current
• Current Study Sponsor: Taiyuan Li
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: The First Affiliated Hospital of Nanchang University
• Verification Date: July 2022