NCT00894725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
Last Updated

May 7, 2009

Status Verified

May 1, 2009

Enrollment Period

4.8 years

First QC Date

May 6, 2009

Last Update Submit

May 6, 2009

Conditions

Colon CancerBenign Disease

Keywords

left colon cancer

Outcome Measures

Primary Outcomes (1)

  • short-term morbidity rate

    30 days

Secondary Outcomes (1)

  • long-term outcome

    5 years

Study Arms (2)

LPS

EXPERIMENTAL

laparoscopic left colonic resection

Procedure: laparoscopic left colonic resection

Open

ACTIVE COMPARATOR

open left colonic resection

Procedure: open left colonic resection

Interventions

laparoscopic left colonic resectionPROCEDURE

laparoscopic colonic resection

LPS
open left colonic resectionPROCEDURE

conventional open colonic resection

Open

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • suitability to elective surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital, Surgical Department

Milan, 20132, Italy

Location

Related Publications (1)

  • Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.

    PMID: 20602506DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Marco Braga, MD

    San Raffaele Vita-Salute University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 7, 2009

Study Start

February 1, 2000

Primary Completion

December 1, 2004

Study Completion

December 1, 2008

Last Updated

May 7, 2009

Record last verified: 2009-05

Locations

IT(1)