A Prospective Feasibility Study for TAMIS

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital University of Copenhagen

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic assisted transanal surgery (TAMIS)

Procedure

all patients included recieve laparoscopic assisted transanal minimally invasive surgery

Primary outcomes

morbidity

Time frame: 30-days

Clavien-Dindo

Secondary outcomes

mortality

Time frame: 30-days

death within 30-days
short-term oncological result

Time frame: 30-days

cancer-free resection margins

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

A Prospective Quality Assurance Feasibility Study of Laparoscopic Assisted Transanal Minimally Invasive Surgery (TAMIS) for Rectal Cancer

Acronym: TAMIS

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Dec 10, 2015
Registry last updated: Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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