Prospective Randomized Study of SILS Versus CLS 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
|Rectal Cancer Adenocarcinoma||Procedure: Single Incision Laparoscopic Surgery||Phase 4|
|Study Design:||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|
- morbidity [ Time Frame: 30 days ]The purpose of this study is to compare 30-days postoperative morbidity between the two groups
- 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
- 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.
- 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.
|Study Start Date:||September 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579721
|Department of Gastroentestinal Surgery, Hvidovre Hospital|
|Hvidovre, Denmark, DK-2650|