Clinical Trials Directory

Trials / Completed

CompletedNCT02626728

A Prospective Feasibility Study for TAMIS

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Hvidovre University Hospital · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURElaparoscopic assisted transanal surgery (TAMIS)all patients included recieve laparoscopic assisted transanal minimally invasive surgery

Timeline

Start date
2015-09-01
Primary completion
2016-09-01
Completion
2016-10-01
First posted
2015-12-10
Last updated
2016-11-22

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02626728. Inclusion in this directory is not an endorsement.