Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-port robotic surgery, Multi-port robotic surgery.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Surgical success rate [Time frame: intraoperative]
Secondary outcome measures (12)
- Operative time [Time frame: intraoperative]
- Intraoperative blood loss [Time frame: intraoperative]
- Incision length [Time frame: intraoperative]
- Total incision length [Time frame: intraoperative]
- Length of stay [Time frame: 1-30 days after surgery]
- Postoperative recovery course [Time frame: 1-14 days after surgery]
- Early morbidity rate [Time frame: 30 days after surgery]
- Pain score [Time frame: 1-3 days after surgery]
- Tumor size [Time frame: 14 days after surgery]
- Incisal margin [Time frame: 14 days after surgery]
- Lymph node detection [Time frame: 14 days after surgery]
- Cosmetic effect [Time frame: 1 month, 6 months and 1 year after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
- Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
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. PMID 37526117
Identifiers
NCT: NCT06943690 · RASILS-01