Demonstrate the Effectiveness to Hemopatch in Controlling Postoperative Bleeding After Laparoscopic Cholecistectomy and in Reducing of Morbidity and Postoperative Hospital Stay
- Conditions
- Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy
- Interventions
- Other: Hemopatch Sealing Hemostat
- Registration Number
- NCT02777307
- Lead Sponsor
- Ospedale Regina Apostolorum
- 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 Description
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 type: iatrogenic enterotomy suture intestinal, iatrogenic lesion of liver parenchyma, bile duct injury. The patient will exclude from the study if one of these intraoperative complication will occur. The patient leaves the protocol if the dissection is done through energy-devices (ultrasound or radiofrequency).
At the end of the laparoscopic cholecstectomy, Hemopatch will be inserted into the peritoneal cavity through the port of 10-12 mm and laid on the cavity of the gallbladder and a drainage will be systematically placed.
It will be given a first-generation cephalosporin antibiotic (one shot).
At 24 hours of VLC a liver ultrasound will be performed and recorded: evaluation of presence of perihepatic fluid, collection or haematoma. It will be noted the volume of drainage which will be removed in first postoperative day. In case of delay removal of drainage, it will be recorded. It will be assessed postoperative pain by VAS scales to 6-12-24 h after surgery. Re-operations and re-hospitalizations will be recorded in prospective data.
Statistical analyzes were performed using the software SPSS for Mac, 22nd edition (SPSS Software, Inc., IL, Chicago). The differences in the distributions will be calculated using the chi-square test or Fisher exact test, depending on the number of cases in the various subgroups and by comparing means (Student t-test, one-way ANOVA test).
The p \< 0.1 will be used as the cut-off for statistical significance in the selection of variables of multivariate analysis in order not to drop important potential predictors.
The statistical significance is conventionally defined with p \<0.05 in all cases considered.
All eligible patients will be adequately informed and informed consent will be signed. The Study will be conducted according to ethical requirements, following the Declaration of Helsinki, and good clinical practice.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Gallbladder stone
- Polyp/neoplasm of gallbladder
- Coagulopathies,
- Medication with antiplatelet agents
- ASA > 3
- Acute cholecystitis
- Main biliaru duct stone
- Acute pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemopatch Sealing Hemostat Hemopatch Sealing Hemostat -
- Primary Outcome Measures
Name Time Method significant reduction in postoperative hospital stay 1 year
- Secondary Outcome Measures
Name Time Method reducing of subhepatic volume drainage 1 year reducing of liver hematoma 1 year reducing of postoperative complications 1 year reducing of rates of reoperation 1 year reducing of re-hospitalization 1 year To assess postoperative pain by the VAS scale 1-10. 1 year
Trial Locations
- Locations (1)
Regina Apostolorum Hospital
🇮🇹Albano Laziale, Rome, Italy