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Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 18, 2012
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katrine Kanstrup Aslak, Hvidovre University Hospital

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

Condition Intervention Phase
Rectal Cancer Adenocarcinoma Procedure: Single Incision Laparoscopic Surgery Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer

Further study details as provided by Katrine Kanstrup Aslak, Hvidovre University Hospital:

Primary Outcome Measures:
  • morbidity [ Time Frame: 30 days ]
    The purpose of this study is to compare 30-days postoperative morbidity between the two groups

Secondary Outcome Measures:
  • 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

  • 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.

  • 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.

Enrollment: 40
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579721

Department of Gastroentestinal Surgery, Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katrine Kanstrup Aslak, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01579721     History of Changes
Other Study ID Numbers: SILS rectal cancer
First Submitted: April 16, 2012
First Posted: April 18, 2012
Last Update Posted: February 5, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases