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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01579721
Other study ID # SILS rectal cancer
Secondary ID
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


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
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