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OpenTrials
Completed

NCT Number: NCT00894725

Laparoscopic Versus Open Left Colonic Resection

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.

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Key information

Conditions

Colon Cancer Benign Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Raffaele Hospital, Surgical Department

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic left colonic resection

Procedure

laparoscopic colonic resection

open left colonic resection

Procedure

conventional open colonic resection

Primary outcomes

  1. short-term morbidity rate

    Time frame: 30 days

Secondary outcomes

  1. long-term outcome

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2004
Study completion
2008
First posted
May 7, 2009
Registry last updated
May 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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