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

May 18, 2016 updated by: A. Liverani, Ospedale Regina Apostolorum

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gallbladder stone
  • Polyp/neoplasm of gallbladder

Exclusion Criteria:

  • Coagulopathies,
  • Medication with antiplatelet agents
  • ASA > 3
  • Acute cholecystitis
  • Main biliaru duct stone
  • Acute pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemopatch Sealing Hemostat
Other: Hemopatch Sealing Hemostat
Place of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy
No Intervention: No Hemopatch Sealing Hemostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
significant reduction in postoperative hospital stay
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Regina Apostolorum

Collaborators

Azienda Ospedaliera San Gerardo di Monza
San Giuseppe Moscati Hospital
Ospedali Riuniti di Foggia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 474 bis/DS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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