A Prospective Feasibility Study for TAMIS

Rectal Cancer Clinical Trial

— TAMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626728
• Other study ID #: 123-TAMIS
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: November 21, 2016
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• laparoscopic assisted transanal surgery (TAMIS)
all patients included recieve laparoscopic assisted transanal minimally invasive surgery

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital University of Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity	Clavien-Dindo	30-days	No
Secondary	mortality	death within 30-days	30-days	No
Secondary	short-term oncological result	cancer-free resection margins	30-days	No