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Laparoscopic Versus Open Left Colonic Resection

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00894725
Enrollment
268
Registered
2009-05-07
Start date
2000-02-29
Completion date
2008-12-31
Last updated
2009-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Disease, Colon Cancer

Keywords

left colon cancer

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.

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.

Interventions

PROCEDURElaparoscopic left colonic resection

laparoscopic colonic resection

PROCEDUREopen left colonic resection

conventional open colonic resection

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
short-term morbidity rate30 days

Secondary

MeasureTime frame
long-term outcome5 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026