Rectal Cancer
Conditions
Brief summary
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.
Interventions
all patients included recieve laparoscopic assisted transanal minimally invasive surgery
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morbidity | 30-days | Clavien-Dindo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 30-days | death within 30-days |
| short-term oncological result | 30-days | cancer-free resection margins |
Countries
Denmark