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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02626728
Acronym
TAMIS
Enrollment
25
Registered
2015-12-10
Start date
2015-09-30
Completion date
2016-10-31
Last updated
2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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

PROCEDURElaparoscopic assisted transanal surgery (TAMIS)

all patients included recieve laparoscopic assisted transanal minimally invasive surgery

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

MeasureTime frameDescription
morbidity30-daysClavien-Dindo

Secondary

MeasureTime frameDescription
mortality30-daysdeath within 30-days
short-term oncological result30-dayscancer-free resection margins

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026