Clinical trial · Interventional
Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer
Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
NCT03597126CI-TRIAL-00055458R-ISRunknownN/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 compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.
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 | Device | — | UNRESOLVED |
| Robot-assisted surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- robot-assisted ISR
- description
- Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic
- interventionNames
- Device: Robot-assisted surgery
- type
- ACTIVE_COMPARATOR
- label
- laparoscopic ISR
- description
- Patients with low rectal cancer undergo laparosocopic intersphincteric resection
- interventionNames
- Device: Laparoscopic surgery
Primary outcomes (4)
- measure
- Change in urinary function
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years \< age \< 80 years 2. Matching the diagnostic criteria; 3. tumor located 3 cm from anal verge 4. Clinically diagnosed cT1-3N0-2 M0 lesions 5. Tumor size of 4 cm or less 6. ASA 1-3 scores; 7. ECOG score is 0-1; 8. Adequate preoperative sphincter function Exclusion Criteria: 1. Requiring a Mile's procedure 2. Fecal incontinence; 3. Previous abdominal surgery 4. Severe mental disease. 5. Intolerance of surgery for severe comorbidities 6. Emergency operation due to complication 7. Pregnant woman or lactating woman
References
Publications (0)
Data not yet available
No reference posted for this study.