A Prospective Feasibility Study for TAMIS

Hvidovre University Hospital

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: laparoscopic assisted transanal surgery (TAMIS)

Study type: Observational

Funder types: Other

Identifiers

NCT02626728

123-TAMIS

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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