Clinical trial · Observational
Feasibility and Safety of Single Port Robot in Colorectal Procedures
NCT03700593CI-TRIAL-00043502unknownClinicalTrials.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)
The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Polyp | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
| Prolapse, Rectal | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Port Robotic Colorectal Surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Port Robotic Colorectal Surgery Patients
- description
- All patients who undergo a single port robot colorectal surgery.
- interventionNames
- Device: Single Port Robotic Colorectal Surgery
Primary outcomes (2)
- measure
- Feasibility of the SP robot
- timeFrame
- 30 days
- description
- Calculating the percentage of cases successfully performed using the SP robot, without conversion.
- measure
- Rate of postoperative complications and mortality of the SP robot
- timeFrame
- 30 days
- description
- Measuring the post-operative morbidity and mortality will be used to evaluate the safety of the SP robot.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study. Exclusion Criteria: * emergency surgery * inability to offer informed consent * pregnant patients
References
Publications (2)
- DERIVEDMarks JH, Agarwal S, Kunkel E, Schoonyoung H, Salem JF. Video Demonstration of an Initial Single-Port Robotic Transanal Total Mesorectal Excision. Dis Colon Rectum. 2021 Aug 1;64(8):e472-e473. doi: 10.1097/DCR.0000000000002139. No abstract available. PMID 34001710
- DERIVEDMarks JH, Kunkel E, Salem JF, Martin CT, Anderson B, Agarwal S. First Clinical Experience With Single-Port Robotic Transanal Minimally Invasive Surgery: Phase II Trial of the Initial 26 Cases. Dis Colon Rectum. 2021 Aug 1;64(8):1003-1013. doi: 10.1097/DCR.0000000000001999. PMID 34001709