Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery

Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer; Surgery
• Intervention / Treatment: Procedure: Single-port robotic surgery; Procedure: Multi-port robotic surgery

Detailed Description

Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. Most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. However, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer，especially in rectal cancer surgery. The purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ren Zhao, MD, PHD; Phone Number: +8618917762018; Email: zhaorensurgeon@aliyun.com
• Study Contact Backup: Name: Kun Liu, MD; Phone Number: +8618121263082; Email: lookiere@126.com

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science & Technology
      • Contact: Jingming Zhai, MD
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital Affiliated to Shandong First Medical University
      • Contact: Leping Li, MD
  • Shanghai
    • Shanghai, Shanghai, China, 201801
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Kun Liu, MD; Phone Number: +8618121263082; Email: lookiere@126.com
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Xian Shen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years < age ≤80 years
• Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge)
• Pathological rectal carcinoma
• Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
• Tumor size of 10 cm or less
• No history of other malignant tumors
• ECOG score is 0-1
• ASA score is Ⅰ-Ⅲ
• Informed consent

Exclusion Criteria:

• Body mass index (BMI) >35 kg/m2
• Familial adenomatous polyposis (FAP)
• Inflammatory bowel disease (IBD)
• Multiple malignant colorectal tumors
• Pregnant woman or lactating woman
• Severe mental disease
• Previous gastrointestinal surgery (except appendectomy ）
• Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery
• Requirement of simultaneous surgery for other disease
• Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery.
• Patients or family members who cannot understand the study program.

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: Single-Port Robotic Surgery; Patients with rectal cancer undergo single-port robotic surgery.	Procedure: Single-port robotic surgery; In this group, patients will be operated using a single-port surgical robot system. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. The surgical procedure followed the principle of total mesorectal excision.; Other Names: SPRS
Active Comparator: Multi-Port Robotic Surgery; Patients with rectal cancer undergo multi-port robotic surgery.	Procedure: Multi-port robotic surgery; In this group, patients will be operated using a multi-port surgical robot system. Surgical instruments enter the abdominal cavity through 4 separate trocars. The surgical procedure followed the principle of total mesorectal excision.; Other Names: MPRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	Proportion of robotic procedures not converted to laparoscopic or open surgery	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time（minutes）	intraoperative
Intraoperative blood loss	Estimated blood loss（milliliters，ml）	intraoperative
Incision length	Incision length（centimeters，cm）	intraoperative
Lymph node detection	Lymph nodes harvested（numbers）	14 days after surgery
Incisal margin	Length of proximal and distal margin （centimeters，cm）	14 days after surgery
Tumor size	The diameter of tumors（centimeters，cm）	14 days after surgery
Total incision length	The sum of all incision lengths（centimeters，cm）	intraoperative
Postoperative recovery course	Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）	1-14 days after surgery
Early morbidity rate	morbidity rate 30 days after surgery	30 days after surgery
Length of stay	The postoperative day when patients complied with the predefined discharge	1-30 days after surgery
Pain score	postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3	1-3 days after surgery
Cosmetic effect	European Organization for Research and Treatment of Cancer Quality of Life	1 month, 6 months and 1 year after surgery
The quality of life-Colorectal	European Organization for Research and Treatment of Cancer Quality of Life	1 month, 6 months and 1 year after surgery
disease free survival rate	1-year disease free survival rate	12 months after surgery

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Shandong Provincial Hospital; The First Affiliated Hospital of Henan University of Science and Technology; First Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Ren Zhao, MD, PHD, Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine; Study Director: Leping Li, MD, Shandong Provincial Hospital; Study Director: Xian Shen, MD, First Affiliated Hospital of Wenzhou Medical University; Study Director: Jingming Zhai, MD, The First Affiliated Hospital of Henan University of Science And Technology

Publications and helpful links

General Publications

• Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Rectal Cancer; Robotic Surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: RASILS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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