Clinical trial · Observational
A Prospective Feasibility Study for TAMIS
A Prospective Quality Assurance Feasibility Study of Laparoscopic Assisted Transanal Minimally Invasive Surgery (TAMIS) for Rectal Cancer
- 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)
Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic assisted transanal surgery (TAMIS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- morbidity
- timeFrame
- 30-days
- description
- Clavien-Dindo
Secondary outcomes (2)
- measure
- mortality
- timeFrame
- 30-days
- description
- death within 30-days
- measure
- short-term oncological result
- timeFrame
- 30-days
- description
- cancer-free resection margins
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion criteria: * rectal cancer with histological diagnosis * tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope. * suitable for elective resection exclusion criteria: * preoperative magnetic resonance imaging (MRI) showing diameter of tumor size \>6 cm * American Society of Anesthesiologists (ASA) class IV and V * anticipated need of intensive care unit (ICU) * history of previous major abdominal surgery * computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs * obese patient with body mass index \>35kg/m2 * those, who do not understand the requirements of the protocol * pregnancy * more than one colorectal tumor
References
Publications (0)
Data not yet available