Clinical trial · Interventional
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
NCT05468944CI-TRIAL-00059777unknownN/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 prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Natural Orifice Specimen Extraction Surgery | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Robotic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transabdominal specimen extraction robotic surgery | Procedure | — | UNRESOLVED |
| Transanal specimen extraction robotic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transanal group
- description
- Participants in this group underwent robotic surgery with transanal specimen extraction
- interventionNames
- Procedure: Transanal specimen extraction robotic surgery
- type
- ACTIVE_COMPARATOR
- label
- Transabdominal group
- description
- Participants in this group underwent robotic surgery with transabdominal specimen extraction
- interventionNames
- Procedure: Transabdominal specimen extraction robotic surgery
Primary outcomes (1)
- measure
- Complication rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 to 75 years; 2. Historically confirmed rectal adenocarcinoma; 3. Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging; 4. cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma; 5. No evidence of distant metastases; 6. A maximum of 5cm in diameter; 7. Body mass index (BMI) ≤ 30 kg / m2; 8. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion); 9. Willing to undergo surgery; 10. Sign the informed consent; Exclusion Criteria: 1. Presence of lateral/inguinal lymph node metastases; 2. Previous history of malignant colorectal tumor; 3. Multiple primary colorectal tumors; 4. Neoadjuvant therapy; 5. Salvage surgery for endoscopic surgery; 6. History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion; 7. Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease; 8. Comorbid with other malignancies within 5 years; 9. ASA ≥ IV and/or ECOG performance status score ≥ 2; 10. Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases; 11. Serious mental illness; 12. Pregnant or lactating women; 13. Uncontrolled infection; 14. Abnormal anal function or anal stenosis;
References
Publications (0)
Data not yet available
No reference posted for this study.