Clinical trial · Interventional
Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery
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
NCT06943690CI-TRIAL-00088897not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-port robotic surgery | Procedure | — | UNRESOLVED |
| Single-port robotic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single-Port Robotic Surgery
- description
- Patients with rectal cancer undergo single-port robotic surgery.
- interventionNames
- Procedure: Single-port robotic surgery
- type
- ACTIVE_COMPARATOR
- label
- Multi-Port Robotic Surgery
- description
- Patients with rectal cancer undergo multi-port robotic surgery.
- interventionNames
- Procedure: Multi-port robotic surgery
Primary outcomes (1)
- measure
- Surgical success rate
- timeFrame
- intraoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDGuo 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