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

Not Applicable

Not yet recruiting

• Conditions: Rectal Cancer; Surgery

• Registration Number: NCT06943690
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-05
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical success rate	intraoperative	Proportion of robotic procedures not converted to laparoscopic or open surgery

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China