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

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ClinicalTrials.gov Identifier: NCT01589146
Recruitment Status : Unknown
Verified April 2012 by Cecilia Becattini, University Of Perugia.
Recruitment status was:  Recruiting
First Posted : May 1, 2012
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Cecilia Becattini, University Of Perugia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
The Primary Study Objective is to Assess the Efficacy and Safety of Extended 4-week Heparin Prophylaxis Compared to Prophylaxis Given for 8±2 Days After Planned Laparoscopic Surgery for Colorectal Cancer. The Clinical Benefit Will be Evaluated as the Difference in the Incidence of VTE or VTE-related Death Occurring Within 30 Days From Surgery in the Two Study Groups. Drug: Heparin, Low-Molecular-Weight Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: short heparin
Experimental: extended heparin Drug: Heparin, Low-Molecular-Weight
4 weeks heparin prophylaxis




Primary Outcome Measures :
  1. symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589146


Contacts
Contact: Cecilia Becattini +39 075 5786424 cecilia.becattini@unipg.it

Locations
Italy
Internal and Cardiovascular Medicine - University of Perugia Recruiting
Perugia, Italy
Sponsors and Collaborators
University Of Perugia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecilia Becattini, MD, University Of Perugia
ClinicalTrials.gov Identifier: NCT01589146     History of Changes
Other Study ID Numbers: Unipg-CRU-01-2012
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Cecilia Becattini, University Of Perugia:
colon-rectal cancer
heparin
prophylaxis
laparoscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action