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

NCT01589146 | Unknown Phase 3

• 1 other identifier: Unipg-CRU-01-2012
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

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; From Surgery in the Two Study Groups.

Keywords

colon-rectal cancer; heparin; prophylaxis; laparoscopy

Outcome Measures

Primary Outcomes (1)

• symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death

  30 days

Study Arms (2)

short heparin

NO INTERVENTION

extended heparin

EXPERIMENTAL

Drug: Heparin, Low-Molecular-Weight

Interventions

Heparin, Low-Molecular-Weight DRUG

4 weeks heparin prophylaxis

extended heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients who had
• planned laparoscopic surgery for

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Internal and Cardiovascular Medicine - University of Perugia

Perugia, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 24253138 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Cecilia Becattini

CONTACT

+39 075 5786424; cecilia.becattini@unipg.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 28, 2012
• First Posted: May 1, 2012
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

IT (1)