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This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with colorectal liver metastases. Half of participants will be operated on by laparoscopic approach and the results obtained will be compared with the results from the other half of patients operated on by open approach.
The safety and efficacy of liver surgery in the treatment of colorectal liver metastases are well established for the open approach. It allows good results in terms of complications, disease free survival and overall survival, and for these reasons it has become the gold standard technique in the treatment of colorectal liver metastases.
On the contrary, the role of laparoscopic liver resection in this context is not so clear nowadays. Generally, laparoscopic surgery offers some advantages such as less pain, shorter hospital stay and better aesthetic results. But the use of laparoscopic approach in liver surgery is still discussing: two international consensus conferences have been held and no strong conclusions have been made. Furthermore for colorectal liver metastases no randomized trials, comparing both techniques, have been published until now.
To assess the feasibility of laparoscopic liver resection for colorectal metastases, the investigators propose this trial in which the patients suitable for laparoscopic approach are randomized to open or laparoscopic group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic group | Experimental | Liver resection performed by laparoscopic approach |
|
| Open group | Active Comparator | Liver resection performed by open approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver resection | Procedure | The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical operative time | Duration of the surgical intervention | Intraoperative |
| Blood losses | Blood loss in milliliter | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Robles Campos, MD; PHD | Hospital Universitario Virgen de la Arrixaca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "Virgen de la Arrixaca" | Murcia | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30701365 | Derived | Robles-Campos R, Lopez-Lopez V, Brusadin R, Lopez-Conesa A, Gil-Vazquez PJ, Navarro-Barrios A, Parrilla P. Open versus minimally invasive liver surgery for colorectal liver metastases (LapOpHuva): a prospective randomized controlled trial. Surg Endosc. 2019 Dec;33(12):3926-3936. doi: 10.1007/s00464-019-06679-0. Epub 2019 Jan 30. |
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| ID | Term |
|---|---|
| D006498 | Hepatectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Transfusion | Number of blood transfusions required during surgical operation | Intraoperative |
| Hospital stay | Days between surgical operation and hospital discharge | Up to 3 months |
| Time between surgery and adjuvant chemotherapy | Days between surgical operation and the beginning of adjuvant chemotherapy | Up to 3 months |
| Mortality | 90 days |
| Morbidity | 90 days |