Clinical trial · Interventional
Single-port Robotic Transanal Total Mesorectal Excision
Efficacy and Safety Assessment of Single-port Robotic Transanal Total Mesorectal Excision for Mid and Low Rectal Cancer: a Phase 2a Trial Based on the IDEAL Framework
- 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 is a phase 2a clinical trial based on the IDEAL framework to evaluate the safety, feasibility and clinical efficacy of single-port robotic transanal total mesorectal excision (SPr-taTME )surgery. For safety, intraoperative adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. The transanal surgical platform consists of a single-port robotic system, while the transabdominal approach can be performed laparoscopically or with single-port robotic assistance.
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 Patients | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-port robotic transanal total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-port robotic transanal total mesorectal excision
- description
- Single-port robotic transanal total mesorectal excision
- interventionNames
- Procedure: Single-port robotic transanal total mesorectal excision
Primary outcomes (2)
- measure
- Intraoperative adverse events and 30-day postoperative complications
- timeFrame
- Intraoperative and postoperative 30 days
- description
- Intraoperative adverse events (device and/or procedure-related). Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines (https://evs.nci.nih.gov/ftp1/CTCAE/About.html). Postoperative complications will refer to any medical occurrence directly attributed to the surgical procedure within the first 30 days.
- measure
- Conversion rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * (1) Mid or low rectal cancer, 0-10 cm from the anal verge (MRI definition); (2) Histological biopsy showing adenocarcinoma; (3) Stage I-III (MRI and abdominal CT), including the downstaged after neoadjuvant therapy; (4) Intention for primary anastomosis; (5) Obtain the informed consent of the patient and his family; (6) Suitable for robotic or laparoscopic surgery. (7) Over 18 years old. Exclusion Criteria: 1. T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRI-scan (staged after (chemo)radiotherapy if applicable) ; 2. The anal sphincter complex or levator anal muscle is involved; 3. Previous prostate or rectal surgery (excluding local excision) ; 4. Emergency surgery was performed due to complications of a rectal tumor; 5. Malignancy other than adenocarcinoma at histological examination; 6. Pregnancy; 7. Signs of acute intestinal obstruction; 8. Multiple colorectal tumours; 9. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis; 10. Planned synchronous abdominal organ resections; 11. Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri; 12. Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class \> III)
References
Publications (0)
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