Clinical trial NCT06943690: Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Surgery
Keywords: Rectal Cancer
Robotic Surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: The First Affiliated Hospital of Henan University of Science and Technology
First posted: 2025-04-24
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Surgical success rate
timeFrame: intraoperative
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Incision length
timeFrame: intraoperative
measure: Total incision length
timeFrame: intraoperative
measure: Length of stay
timeFrame: 1-30 days after surgery
measure: Postoperative recovery course
timeFrame: 1-14 days after surgery
measure: Early morbidity rate
timeFrame: 30 days after surgery
measure: Pain score
timeFrame: 1-3 days after surgery
measure: Tumor size
timeFrame: 14 days after surgery
measure: Incisal margin
timeFrame: 14 days after surgery
measure: Lymph node detection
timeFrame: 14 days after surgery
measure: Cosmetic effect
timeFrame: 1 month, 6 months and 1 year after surgery
measure: The quality of life-Colorectal
timeFrame: 1 month, 6 months and 1 year after surgery
measure: disease free survival rate
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Henan
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
name: Ren Zhao, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Leping Li, MD
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Xian Shen, MD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jingming Zhai, MD
role: STUDY_DIRECTOR
References:
citation: 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.