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

NCT06943690 | Not Yet Recruiting DMC

• 1 other identifier: RASILS-01
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Rectal Cancer; Surgery

Keywords

Rectal Cancer; Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• Surgical success rate

  Proportion of robotic procedures not converted to laparoscopic or open surgery

  intraoperative

Secondary Outcomes (14)

• Operative time

  intraoperative

• Intraoperative blood loss

  intraoperative

• Incision length

  intraoperative

• Total incision length

  intraoperative

• Length of stay

  1-30 days after surgery

Study Arms (2)

Single-Port Robotic Surgery

EXPERIMENTAL

Patients with rectal cancer undergo single-port robotic surgery.

Procedure: Single-port robotic surgery

Multi-Port Robotic Surgery

ACTIVE COMPARATOR

Patients with rectal cancer undergo multi-port robotic surgery.

Procedure: Multi-port robotic surgery

Interventions

Single-port robotic surgery PROCEDURE

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.

Also known as: SPRS

Single-Port Robotic Surgery

Multi-port robotic surgery PROCEDURE

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.

Also known as: MPRS

Multi-Port Robotic Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shandong Provincial Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator

Study Sites (4)

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, 471003, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 201801, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

• 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.

  PMID: 37526117 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

sperm releasing substance

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ren Zhao, MD, PHD

  Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Ren Zhao, MD, PHD

CONTACT

+8618917762018; zhaorensurgeon@aliyun.com

Kun Liu, MD

CONTACT

+8618121263082; lookiere@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physicion

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)