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Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

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ClinicalTrials.gov Identifier: NCT01579721
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Katrine Kanstrup Aslak, Hvidovre University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Rectal Cancer Adenocarcinoma Procedure: Single Incision Laparoscopic Surgery Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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



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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

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


Locations
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Denmark
Department of Gastroentestinal Surgery, Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katrine Kanstrup Aslak, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01579721    
Other Study ID Numbers: SILS rectal cancer
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases