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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Department of Gastroentestinal Surgery, Hvidovre Hospital|
|Hvidovre, Denmark, DK-2650|