Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic CholecistectomyNCT02777307
Demonstrate the Effectiveness to Hemopatch in Controlling Postoperative Bleeding After Laparoscopic Cholecistectomy and in Reducing of Morbidity and Postoperative Hospital Stay
A study testing Hemopatch Sealing Hemostat in people with Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy, run by Ospedale Regina Apostolorum at 1 site in Italy.
Trial summary
Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing of postperative fluid collection after laparoscopic cholecistectomy, morbidity and postoperative hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy
- What is being tested?
- Hemopatch Sealing Hemostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gallbladder stone
- Polyp/neoplasm of gallbladder
Who cannot join
- Coagulopathies,
- Medication with antiplatelet agents
- ASA > 3
- Acute cholecystitis
- Main biliaru duct stone
- Acute pancreatitis
Trial locations and contacts
1 site in 1 country.
Italy1 site
Regina Apostolorum Hospital
Albano Laziale, Rome, 00041
Andrea Liverani, MD, +39693298501, aliverani@reginaapostolorum.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Hemopatch Sealing Hemostat
- Keywords
- Laparoscopic, Cholecistectomy, Collection, Bleeding, reoperation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemopatch Sealing HemostatOther
Place of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch Sealing Hemostat | Experimental | Not described Receives: Other: Hemopatch Sealing Hemostat |
| No Hemopatch Sealing Hemostat | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant reduction in postoperative hospital stay
Measured: 1 year
Secondary outcomes (6)
reducing of subhepatic volume drainage
Measured: 1 year
reducing of liver hematoma
Measured: 1 year
reducing of postoperative complications
Measured: 1 year
reducing of rates of reoperation
Measured: 1 year
reducing of re-hospitalization
Measured: 1 year
To assess postoperative pain by the VAS scale 1-10.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic CholecistectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Regina Apostolorum
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza, San Giuseppe Moscati Hospital, Ospedali Riuniti di Foggia
- Responsible party
- Principal investigator, A. Liverani, Ospedale Regina Apostolorum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777307
- Sponsor's protocol ID
- 474 bis/DS
- Status last verified
- May 2016
- First submitted
- 17 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014.
PubMed 24729905Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1.
PubMed 25085811Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch(R) as a hemostatic agent in zero-ischemia partial nephrectomy. World J Urol. 2015 Oct;33(10):1527-34. doi: 10.1007/s00345-014-1404-4. Epub 2014 Sep 20.
PubMed 25239500Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6.
PubMed 25106082Stokes ME, Ye X, Shah M, Mercaldi K, Reynolds MW, Rupnow MF, Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011 May 31;11:135. doi: 10.1186/1472-6963-11-135.
PubMed 21627788Keus F, Wetterslev J, Gluud C, Gooszen HG, van Laarhoven CJ. Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed. J Clin Epidemiol. 2010 Mar;63(3):246-56. doi: 10.1016/j.jclinepi.2009.08.023. Epub 2009 Dec 11.
PubMed 20004553
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hemopatch in Reducing of Postoperative Bleeding After Laparoscopic Cholecystectomy: Prosective and Multicenter Study
- ClinicalTrials.gov ID
- NCT02777307
- Acronym / sponsor ID
- 474 bis/DS
- Keywords
- Laparoscopic, Cholecistectomy, Collection, Bleeding, reoperation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ospedale Regina ApostolorumUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza, San Giuseppe Moscati Hospital, Ospedali Riuniti di Foggia
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemopatch Sealing Hemostat | Experimental | Other: Hemopatch Sealing Hemostat |
| No Hemopatch Sealing Hemostat | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gallbladder stone
- Polyp/neoplasm of gallbladder
Key exclusion criteria (6 listed)
- Coagulopathies,
- Medication with antiplatelet agents
- ASA > 3
- Acute cholecystitis
- Main biliaru duct stone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemopatch Sealing HemostatPlace of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy | Other | Hemopatch Sealing Hemostat |
Primary outcome
significant reduction in postoperative hospital stay
Time frame: 1 year
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Results publication: PubMed 24729905Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014.
- Results publication: PubMed 25085811Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1.
- Results publication: PubMed 25239500Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch(R) as a hemostatic agent in zero-ischemia partial nephrectomy. World J Urol. 2015 Oct;33(10):1527-34. doi: 10.1007/s00345-014-1404-4. Epub 2014 Sep 20.
- Results publication: PubMed 25106082Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6.
- Results publication: PubMed 21627788Stokes ME, Ye X, Shah M, Mercaldi K, Reynolds MW, Rupnow MF, Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011 May 31;11:135. doi: 10.1186/1472-6963-11-135.
- Results publication: PubMed 20004553Keus F, Wetterslev J, Gluud C, Gooszen HG, van Laarhoven CJ. Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed. J Clin Epidemiol. 2010 Mar;63(3):246-56. doi: 10.1016/j.jclinepi.2009.08.023. Epub 2009 Dec 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemopatch Sealing Hemostat in people with Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy, run by Ospedale Regina Apostolorum at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant reduction in postoperative hospital stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02777307, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.