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A Prospective Feasibility Study for TAMIS

NCT ID: NCT02626728

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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laparoscopic assisted transanal surgery (TAMIS)

all patients included recieve laparoscopic assisted transanal minimally invasive surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette Willaume Christoffersen

M.D, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette W Christoffersen, M.D, PhD

Role: STUDY_CHAIR

Hvidovre Hospital University of Copenhagen

Locations

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Hvidovre Hospital University of Copenhagen

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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123-TAMIS

Identifier Type: -

Identifier Source: org_study_id