ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. (PRO-LAPS I)

April 28, 2012 updated by: Cecilia Becattini, University Of Perugia

ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY.

Overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of VTE.

The aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Perugia, Italy
        • Recruiting
        • Internal and Cardiovascular Medicine - University of Perugia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients who had
  • planned laparoscopic surgery for
  • colorectal cancer will be included in the study provided no exclusion criteria will be found

Exclusion Criteria:

  • age < 18 years
  • surgery for non-cancer disease
  • duration of surgery < 45 min
  • other indication for anticoagulant therapy
  • known cerebral metastases
  • kidney or liver failure
  • known hemorrhagic diathesis or high risk for bleeding
  • history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia
  • pregnancy or lactation
  • refusal of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: short heparin
EXPERIMENTAL: extended heparin
Drug: Heparin, Low-Molecular-Weight
4 weeks heparin prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

April 28, 2012

First Submitted That Met QC Criteria

April 28, 2012

First Posted (ESTIMATE)

May 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 28, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Unipg-CRU-01-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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