A Prospective Feasibility Study for TAMIS (TAMIS)

November 21, 2016 updated by: Mette Willaume Christoffersen, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Rectal Cancer

Intervention / Treatment

Procedure: laparoscopic assisted transanal surgery (TAMIS)

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Hvidovre, Denmark, 2650
    - Hvidovre Hospital University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and distant metastasis, will be offered the operative procedure with TAMIS technique.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity Time Frame: 30-days	Clavien-Dindo	30-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality Time Frame: 30-days	death within 30-days	30-days
short-term oncological result Time Frame: 30-days	cancer-free resection margins	30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

Study Chair: Mette W Christoffersen, M.D, PhD, Hvidovre Hospital University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria