The Value of Laparoscopic Ultrasound in Patients Undergoing Laparoscopic Resection for Cancer of the Colon or Rectum

Summary

The following project deals with a Danish multicenter trial that evaluates the value of Laparoscopic Ultrasound examination (LUS) in laparoscopic surgery for colon and rectum cancer (CRC).

The project "The value of laparoscopic ultrasound in patients undergoing laparoscopic resection for colon and rectum cancer. - A prospective randomized trial" is part of a ph.d- study at the University of Southern Denmark in collaboration with several surgical departments at hospitals in Southern Denmark.

The primary purpose is to investigate whether the use of laparoscopic ultrasound examination (LUS) will change the stage of the tumor, lymph node and metastasis (TNM stage) and the surgical approach in patients undergoing laparoscopic surgery for colorectal cancer (CRC).

As a secondary objective; an evaluation of the use of LUS will change the treatment strategy for the individual patient with CRC.

As an other objective we wants to investigate whether the use of contrast enhanced ultrasound examination in connection with LUS procedure increases the number of detected liver metastases.

Conditions

• Colon Cancer
• Rectum Cancer
• Liver Metastases

Interventions

DEVICE

Lap+Lus

In the standard arm (Lap) the conditions at the abdomen is only assessed by laparoscopy immediately prior to the resection. In the intervention arm the intra-abdominal conditions are also assessed by laparoscopy, but then supplemented with a laparoscopic ultrasound examination of the primary tumor, liver and retroperitoneum. All patients are given an CT scan of the abdomen after 3 months.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Svendborg Hospital

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Signe bremholm Rasmussen, MD · Odense University Hospital

• Michael Bau Mortensen, professor · Odense University Hospital

• Claus Fristrup, ph.d · Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-12-31

Completion

2015-04-30

Countries

• Denmark

Study Locations