Clinical Trial: Demonstrate the Effectiveness to Hemopatch in Controlling Postoperative Bleeding After Laparoscopic Cholecistectomy and in Reducing of Morbidity and Postoperative Hospital Stay

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Efficacy of Hemopatch in Reducing of Postoperative Bleeding After Laparoscopic Cholecystectomy: Prosective and Multicenter Study

Brief Summary: Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing of postperative fluid collection after laparoscopic cholecistectomy, morbidity and postoperative hospital stay.

Detailed Summary:

Prospective Multicenter Longitudinal and cohort. The sample size of 150 patients was calculated in order to obtain a statistical power adequacy or higher (Type I error - Alpha = 0.05, Type II Error - Beta = 0:20), assuming the 1-day to reduce the postoperative stay with use Hemopatch compared to the control (average stay little 3 +/- 2 days).

Primary endpoint:

- significant reduction in postoperative hospital stay

Secondary endpoints:

  • reduction of subhepatic blood liquid volume
  • reduction of liver hematoma
  • reduction of postooperative complications as deep surgical site
  • reduction rates of reoperation
  • reduction in readmission rates
  • postoperative pain on the VAS scale 1-10.

The results obtained in relation to primary and secondary objectives will be compared with a control group of case-matched.

Inclusion Criteria:

- Between the ages of 18-75 years, calculus of gallbladder (micro- and macro-lithiasis), polyp/neoplasm of gallbladder

Exclusion Criteria:

- Coagulopathies, medication with antiplatelet drugs, ASA > 3, acute cholecystitis, simultaneous calculus of main biliary duct, acute pancreatitis.

The patient will enroll if cholecystectomy is performed laparoscopically, if it is not a complication occurred intraoperative t
Sponsor: Ospedale Regina Apostolorum

Current Primary Outcome: significant reduction in postoperative hospital stay [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • reducing of subhepatic volume drainage [ Time Frame: 1 year ]
  • reducing of liver hematoma [ Time Frame: 1 year ]
  • reducing of postoperative complications [ Time Frame: 1 year ]
  • reducing of rates of reoperation [ Time Frame: 1 year ]
  • reducing of re-hospitalization [ Time Frame: 1 year ]
  • To assess postoperative pain by the VAS scale 1-10. [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Ospedale Regina Apostolorum

Dates:
Date Received: May 17, 2016
Date Started: June 2016
Date Completion: May 2017
Last Updated: May 18, 2016
Last Verified: May 2016