Back to resultsONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. (PRO-LAPS I)
Primary Purpose
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
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Heparin, Low-Molecular-Weight
Sponsored by
About this trial
This is an interventional prevention trial for The Primary Study Objective is to Assess the Efficacy and focused on measuring colon-rectal cancer, heparin, prophylaxis, laparoscopy
Eligibility 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.
Sites / Locations
- Internal and Cardiovascular Medicine - University of PerugiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
short heparin
extended heparin
Arm Description
Outcomes
Primary Outcome Measures
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01589146
Brief Title
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.
Acronym
PRO-LAPS I
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.
Keywords
colon-rectal cancer, heparin, prophylaxis, laparoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
short heparin
Arm Type
No Intervention
Arm Title
extended heparin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Heparin, Low-Molecular-Weight
Intervention Description
4 weeks heparin prophylaxis
Primary Outcome Measure Information:
Title
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Becattini
Phone
+39 075 5786424
Email
cecilia.becattini@unipg.it
Facility Information:
Facility Name
Internal and Cardiovascular Medicine - University of Perugia
City
Perugia
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
24253138
Citation
Vedovati MC, Becattini C, Rondelli F, Boncompagni M, Camporese G, Balzarotti R, Mariani E, Flamini O, Pucciarelli S, Donini A, Agnelli G. A randomized study on 1-week versus 4-week prophylaxis for venous thromboembolism after laparoscopic surgery for colorectal cancer. Ann Surg. 2014 Apr;259(4):665-9. doi: 10.1097/SLA.0000000000000340.
Results Reference
derived
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ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.
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