Clinical trial · Interventional
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| From Surgery in the Two Study Groups. | — | UNRESOLVED | — |
| Prophylaxis Given for 8±2 Days After Planned Laparoscopic | — | UNRESOLVED | — |
| Safety of Extended 4-week Heparin Prophylaxis Compared to | — | UNRESOLVED | — |
| Surgery for Colorectal Cancer. | Colon Neoplasm | PROBABILISTIC | 0.70 |
| The Clinical Benefit Will be Evaluated as the Difference in | — | UNRESOLVED | — |
| the Incidence of VTE or VTE-related Death Occurring Within 30 Days | — | UNRESOLVED | — |
| The Primary Study Objective is to Assess the Efficacy and | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heparin, Low-Molecular-Weight | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- short heparin
- type
- EXPERIMENTAL
- label
- extended heparin
- interventionNames
- Drug: Heparin, Low-Molecular-Weight
Primary outcomes (1)
- measure
- symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVedovati 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