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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Neoplasms; Robotic Surgery; Natural Orifice Specimen Extraction Surgery
• Intervention / Treatment: Procedure: Transanal specimen extraction robotic surgery; Procedure: Transabdominal specimen extraction robotic surgery

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
• Enrollment (Anticipated): 556
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Contact: Xishan Wang
  • Changsha, China
    • The Second Xiangya Hospital, Central South University
    • Contact: Hongliang Yao
  • Chongqing, China
    • Three Gorges Hospital Affiliated to Chongqing University
    • Contact: Dehai Xiong
  • Fuzhou, China
    • Fujian Cancer Hospital
    • Contact: Chunkang Yang
  • Ganzhou, China
    • The First Affiliated Hospital of Gannan Medical University
    • Contact: Xiangfu Zeng
  • Guangzhou, China
    • The Second Affiliated Hospital, Sun Yat-Sen University
    • Contact: Fanghai Han
  • Harbin, China
    • The Second Affiliated Hospital of Harbin Medical University
    • Contact: Guiyu Wang
  • Nanchang, China
    • The First Affiliated Hospital of NanChang University
    • Contact: Taiyuan Li
  • Shanghai, China
    • Zhongshan Hospital, Fudan University
    • Contact: Ye Wei
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiaotong University
    • Contact: Junjun She
  • Xiamen, China, 361004
    • Zhongshan Hospital of Xiamen University
    • Contact: Jianchun Cai
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Junhong Hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transanal group; Participants in this group underwent robotic surgery with transanal specimen extraction	Procedure: Transanal specimen extraction robotic surgery; Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Active Comparator: Transabdominal group; Participants in this group underwent robotic surgery with transabdominal specimen extraction	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
EORTC QLQ-C30	To assess the quality of life of all cancer patients.	1 day before operation, 1, 3, 6 months postoperatively.
EORTC QLQ-C38	To assess the quality of life in patients with rectal cancer.	1 day before operation, 1, 3, 6 months postoperatively.
Tumor size	To assess the quality of surgical specimens.	Up to 30 days postoperatively.
Number of Histopathological type	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Degree of differentiation	To assess the quality of surgical specimens and postoperative pathological evaluation.	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.	Up to 30 days postoperatively.
Number of lymph node dissection and metastasis	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Nerve vessel involvement rate	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Hospitalization costs	To assess the financial burden difference.	Up to 30 days.
Local recurrence rate	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.
The incidence rate of distant metastasis	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.
Tumor-free survival rates	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.
Overall survival rate	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.

Collaborators and Investigators

• Sponsor: Taiyuan Li

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: RO220624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No