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Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katrine Kanstrup Aslak, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01579721
First received: April 16, 2012
Last updated: February 3, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579721

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

No publications provided

Responsible Party: Katrine Kanstrup Aslak, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01579721     History of Changes
Other Study ID Numbers: SILS rectal cancer
Study First Received: April 16, 2012
Last Updated: February 3, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on May 16, 2013