Skip to main content
OpenTrials
Completed

NCT Number: NCT01579721

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rectal Cancer Adenocarcinoma Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroentestinal Surgery, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

single incision laparoscopic surgery

Procedure

Single incision laparoscopic surgery for rectal cancer

Primary outcomes

  1. morbidity

    Time frame: 30 days

    The purpose of this study is to compare 30-days postoperative morbidity between the two groups

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 18, 2012
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.