Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579721
• Other study ID #: SILS rectal cancer
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2012
• Last updated: February 3, 2013
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Single Incision Laparoscopic Surgery
Single incision laparoscopic surgery for rectal cancer

Locations

Country	Name	City	State
Denmark	Department of Gastroentestinal Surgery, Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity	The purpose of this study is to compare 30-days postoperative morbidity between the two groups	30 days	No
Secondary	immunology	to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups	72 hours postoperatively	No
Secondary	postoperative outcome	to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.	5 days postoperatively	No
Secondary	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.	30 days	No