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Laparoscopic Versus Open Left Colonic Resection

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ClinicalTrials.gov Identifier: NCT00894725
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : May 7, 2009
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele

Brief Summary:

The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.

268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.


Condition or disease Intervention/treatment Phase
Colon Cancer Benign Disease Procedure: laparoscopic left colonic resection Procedure: open left colonic resection Phase 3

Detailed Description:

The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.

Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
Study Start Date : February 2000
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: LPS
laparoscopic left colonic resection
Procedure: laparoscopic left colonic resection
laparoscopic colonic resection
Active Comparator: Open
open left colonic resection
Procedure: open left colonic resection
conventional open colonic resection



Primary Outcome Measures :
  1. short-term morbidity rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. long-term outcome [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • suitability to elective surgery

Exclusion Criteria:

  • cancer infiltrating adjacent organs assessed by computed tomography
  • cardiovascular dysfunction (New York Heart Association class > 3)
  • respiratory dysfunction (arterial pO2 < 70 mmHg)
  • hepatic dysfunction (Child-Pugh class C)
  • ongoing infection
  • plasma neutrophil level < 2.0x109/L

Information from the National Library of Medicine

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): NCT00894725


Locations
Italy
San Raffaele Hospital, Surgical Department
Milan, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Director: Marco Braga, MD San Raffaele Vita-Salute University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Braga MD, San Raffaele Vita-Salute University
ClinicalTrials.gov Identifier: NCT00894725     History of Changes
Other Study ID Numbers: hmsxLPS09
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

Keywords provided by Università Vita-Salute San Raffaele:
left colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases