Know Cancer

or
forgot password

Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial


Phase 3
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Benign Disease

Thank you

Trial Information

Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

short-term morbidity rate

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Marco Braga, MD

Investigator Role:

Study Director

Investigator Affiliation:

San Raffaele Vita-Salute University

Authority:

Italy: Ethics Committee

Study ID:

hmsxLPS09

NCT ID:

NCT00894725

Start Date:

February 2000

Completion Date:

December 2008

Related Keywords:

  • Colon Cancer
  • Benign Disease
  • left colon cancer
  • Colonic Neoplasms

Name

Location