The Primary Study Objective is to Assess the Efficacy andPhase 3PRO-LAPS INCT01589146
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.
A Phase 3 study testing Heparin, Low-Molecular-Weight in people with The Primary Study Objective is to Assess the Efficacy and and Safety of Extended 4-week Heparin Prophylaxis Compared to, run by University Of Perugia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- Heparin, Low-Molecular-Weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients who had
- planned laparoscopic surgery for
- colorectal cancer will be included in the study provided no exclusion criteria will be found
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Internal and Cardiovascular Medicine - University of Perugia
Perugia
About this study
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.
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.
- Conditions
- 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
- Being tested
- Heparin, Low-Molecular-Weight
- Keywords
- colon-rectal cancer, heparin, prophylaxis, laparoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin, Low-Molecular-WeightDrug
4 weeks heparin prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| short heparin | No intervention | Not described |
| extended heparin | Experimental | Not described Receives: Drug: Heparin, Low-Molecular-Weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Primary Study Objective is to Assess the Efficacy andStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Becattini, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589146
- Sponsor's protocol ID
- Unipg-CRU-01-2012
- Acronym
- PRO-LAPS I
- Status last verified
- Apr 2012
- First submitted
- 28 Apr 2012
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24253138
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01589146
- Acronym / sponsor ID
- PRO-LAPS I / Unipg-CRU-01-2012
- Conditions
- 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
- Keywords
- colon-rectal cancer, heparin, prophylaxis, laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short heparin | No intervention | – |
| extended heparin | Experimental | Drug: Heparin, Low-Molecular-Weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients who had
- planned laparoscopic surgery for
- colorectal cancer will be included in the study provided no exclusion criteria will be found
Key exclusion criteria (10 listed)
- age < 18 years
- surgery for non-cancer disease
- duration of surgery < 45 min
- other indication for anticoagulant therapy
- known cerebral metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin, Low-Molecular-Weight4 weeks heparin prophylaxis | Drug | extended heparin |
Primary outcome
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Derived from this study: PubMed 24253138Vedovati 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin, Low-Molecular-Weight in people with The Primary Study Objective is to Assess the Efficacy and and Safety of Extended 4-week Heparin Prophylaxis Compared to, run by University Of Perugia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Becattini (+39 075 5786424, cecilia.becattini@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.