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

NCT ID: NCT06943690

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2027-06-30

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.

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.

Conditions

Rectal Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-Port Robotic Surgery

Patients with rectal cancer undergo single-port robotic surgery.

Group Type: EXPERIMENTAL

Single-port robotic surgery

Intervention Type: 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.

Multi-Port Robotic Surgery

Patients with rectal cancer undergo multi-port robotic surgery.

Group Type: ACTIVE_COMPARATOR

Multi-port robotic surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SPRS; MPRS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Ren

Chief Physicion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ren Zhao, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine

Leping Li, MD

Role: STUDY_DIRECTOR

Shandong Provincial Hospital

Xian Shen, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital of Wenzhou Medical University

Jingming Zhai, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Henan University of Science and Technology

Locations

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Central Contacts

Ren Zhao, MD, PHD

Role: CONTACT

zhaorensurgeon@aliyun.com

+8618917762018

Kun Liu, MD

Role: CONTACT

lookiere@126.com

+8618121263082

Facility Contacts

Jingming Zhai, MD

Role: primary

Leping Li, MD

Role: primary

Kun Liu, MD

Role: primary

lookiere@126.com

+8618121263082

Xian Shen, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 37526117 (View on PubMed)

Other Identifiers

RASILS-01

Identifier Type: -

Identifier Source: org_study_id