Clinical trial · Observational
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial
- 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 aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
| Robotic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Robotic group
- description
- Patients received robotic surgery for middle and low rectal cancer
- interventionNames
- Procedure: Robotic surgery
- label
- Laparoscopic group
- description
- Patients received laparoscopic surgery for middle and low rectal cancer
- interventionNames
- Procedure: Laparoscopic surgery
Primary outcomes (1)
- measure
- 3-year postoperative disease-free survival rate
- timeFrame
- From surgery to three years postoperatively
- description
- Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: 1. Age from 18 years to 80 years; 2. American Society of Anesthesiologists (ASA) class I - III; 3. Histologically proved rectal adenocarcinoma; 4. Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy; 5. Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI; 6. No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc; 7. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; 8. Received either robotic or laparoscopic surgery; 9） Surgery with radical intent; 10\) Informed consent. Exclusion criteria 1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc; 2. Synchronous colon surgery for multiple colorectal tumors or other schedules; 3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.); 4. Co-existent inflammatory bowel disease; 5. Pregnancy or lactation; 6. Patients received treatment other than preoperative radio- or chemoradiotherapy.
References
Publications (0)
Data not yet available