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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00894725
Other study ID # hmsxLPS09
Secondary ID
Status Completed
Phase Phase 3
First received May 6, 2009
Last updated May 6, 2009
Start date February 2000
Est. completion date December 2008

Study information

Verified date May 2009
Source Università Vita-Salute San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date December 2008
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic left colonic resection
laparoscopic colonic resection
open left colonic resection
conventional open colonic resection

Locations

Country Name City State
Italy San Raffaele Hospital, Surgical Department Milan

Sponsors (1)

Lead Sponsor Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary short-term morbidity rate 30 days No
Secondary long-term outcome 5 years No
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