Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 5, 2013
February 1, 2013
1.1 years
April 16, 2012
February 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
morbidity
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
30 days
Secondary Outcomes (3)
immunology
72 hours postoperatively
postoperative outcome
5 days postoperatively
oncology
30 days
Study Arms (2)
SILS-group
EXPERIMENTAL20 patients undergoing Single Incision Laparoscopic Surgery
CLS-group
NO INTERVENTION20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer
Interventions
Single incision laparoscopic surgery for rectal cancer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Linguistic, physical or psychological barriers precluding oral and written consent.
- History of intestinal surgery (excl. appendectomy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroentestinal Surgery, Hvidovre Hospital
Hvidovre, DK-2650, Denmark
Related Publications (1)
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.
PMID: 25380743DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 18, 2012
Study Start
September 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 5, 2013
Record last verified: 2013-02