Back to resultsProspective Randomized Study of SILS Versus CLS for Rectal Cancer
Primary Purpose
Rectal Cancer, Adenocarcinoma
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Single Incision Laparoscopic Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility 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).
Sites / Locations
- Department of Gastroentestinal Surgery, Hvidovre Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SILS-group
CLS-group
Arm Description
20 patients undergoing Single Incision Laparoscopic Surgery
20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer
Outcomes
Primary Outcome Measures
morbidity
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
Secondary Outcome Measures
immunology
to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups
postoperative outcome
to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.
oncology
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.
Full Information
NCT ID
NCT01579721
First Posted
April 16, 2012
Last Updated
February 3, 2013
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01579721
Brief Title
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
Official Title
Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SILS-group
Arm Type
Experimental
Arm Description
20 patients undergoing Single Incision Laparoscopic Surgery
Arm Title
CLS-group
Arm Type
No Intervention
Arm Description
20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer
Intervention Type
Procedure
Intervention Name(s)
Single Incision Laparoscopic Surgery
Intervention Description
Single incision laparoscopic surgery for rectal cancer
Primary Outcome Measure Information:
Title
morbidity
Description
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
Time Frame
30 days
Secondary Outcome Measure Information:
Title
immunology
Description
to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups
Time Frame
72 hours postoperatively
Title
postoperative outcome
Description
to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.
Time Frame
5 days postoperatively
Title
oncology
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Department of Gastroentestinal Surgery, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25380743
Citation
Bulut O, Aslak KK, Levic K, Nielsen CB, Romer E, Sorensen S, Christensen IJ, Nielsen HJ. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery: effects on postoperative pain and the stress response to surgery. Tech Coloproctol. 2015 Jan;19(1):11-22. doi: 10.1007/s10151-014-1237-6. Epub 2014 Nov 8.
Results Reference
derived
Learn more about this trial
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
We'll reach out to this number within 24 hrs