Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

February 3, 2013 updated by: Katrine Kanstrup Aslak, Hvidovre University Hospital

Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer

Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.

Design: randomized, prospective clinical study Patients: 40 patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, DK-2650
        • Department of Gastroentestinal Surgery, Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients > 18 years of age.
  • ASA I-III.
  • Tumor-location: maximum 15 cm from the anal verge.
  • No involvement of neighbouring organs.
  • No distant metastasis.

Exclusion Criteria:

  • Linguistic, physical or psychological barriers precluding oral and written consent.
  • History of intestinal surgery (excl. appendectomy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SILS-group
20 patients undergoing Single Incision Laparoscopic Surgery
Procedure: Single Incision Laparoscopic Surgery
Single incision laparoscopic surgery for rectal cancer
No Intervention: CLS-group
20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity
Time Frame: 30 days
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunology
Time Frame: 72 hours postoperatively
to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups
72 hours postoperatively
postoperative outcome
Time Frame: 5 days postoperatively
to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.
5 days postoperatively
oncology
Time Frame: 30 days
Comparison of the oncological results (quality of specimen, completeness of mesorectal fascia, circumferential resection margin, number of harvested lymphnodes, TNM-classification) between the two groups.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 3, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILS rectal cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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