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
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-
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Hvidovre, Denmark, DK-2650
- Department of Gastroentestinal Surgery, Hvidovre Hospital
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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
|
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.
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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
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.
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.