ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

From Surgery in the Two Study Groups. Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01589146
• Other study ID #: Unipg-CRU-01-2012
• Status: Recruiting
• Phase: Phase 3
• First received: April 28, 2012
• Last updated: April 28, 2012
• Start date: September 2010

Study information

• Verified date: April 2012
• Source: University Of Perugia
• Contact: Cecilia Becattini
• Phone: +39 075 5786424
• Email: cecilia.becattini[@]unipg.it
• Is FDA regulated: No
• Health authority: Italy: 'Steering Committee'
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms
• From Surgery in the Two Study Groups.
• Prophylaxis Given for 8±2 Days After Planned Laparoscopic
• Safety of Extended 4-week Heparin Prophylaxis Compared to
• 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
• The Primary Study Objective is to Assess the Efficacy and

Intervention

Drug:
• Heparin, Low-Molecular-Weight
4 weeks heparin prophylaxis

Locations

Country	Name	City	State
Italy	Internal and Cardiovascular Medicine - University of Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death		30 days	No