Laparoscopic Versus Open Left Colonic Resection

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00894725
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Colon Cancer
Benign Disease
Procedure: laparoscopic left colonic resection
Procedure: open left colonic resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • short-term morbidity rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • long-term outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: February 2000
Study Completion Date: December 2008
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Università Vita-Salute San Raffaele

Additional 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
Study First Received: May 6, 2009
Last Updated: May 6, 2009
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 27, 2014