CholelithiasisCLCHSNCT01139385
Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery
An observational study of Cholelithiasis, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Harmonic scalpel and Traditional
- Type of treatment
- Surgery or procedure
- How many people
- 218 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Feb 2014
- Phase
- Observational
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with gallstone undergoing cholecystectomy in day surgery setting
Who may be able to join
- Symptomatic Cholelithiasis
- Age under 65 yr old
- BMI under 35
- ASA I or II
Who cannot join
- Acute cholecystitis
- Suspect of common bile duct stones
Trial locations and contacts
1 site in 1 country.
Italy1 site
Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome
Rome, Italy, 00189
About this study
Official title: Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study
The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting
- Conditions
- Cholelithiasis
- Being tested
- Harmonic scalpel, Traditional
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic scalpelProcedure or surgery
The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery
TraditionalProcedure or surgery
The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips
| Study group | Role | What they receive |
|---|---|---|
| clipless | laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device Receives: Procedure: Harmonic scalpel | |
| traditional | laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip Receives: Procedure: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness closure of the cystic duct
the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak
Measured: at 1 months
Secondary outcomes (2)
postoperative complication
the presence of postoperative complication is investigated
Measured: 1 month
efficacy and safety of the use of harmonic scalpel performing cholecystectomy
the efficacy and safety of the use of harmonic scalpel performing cholecystectomy is assessed by evaluating the operative time, the presence of major or minor intraoperative complication and the postoperative complication.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Saverio Mari, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139385
- Sponsor's protocol ID
- DS-001
- Acronym
- CLCHS
- Status last verified
- Dec 2013
- First submitted
- 2 Jun 2010
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01139385
- Acronym / sponsor ID
- CLCHS / DS-001
- Conditions
- Cholelithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Jun 2010 (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.
The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clipless | – | Procedure: Harmonic scalpellaparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device |
| traditional | – | Procedure: Traditionallaparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with gallstone undergoing cholecystectomy in day surgery setting
Key inclusion criteria (4 listed)
- Symptomatic Cholelithiasis
- Age under 65 yr old
- BMI under 35
- ASA I or II
Key exclusion criteria (2 listed)
- Acute cholecystitis
- Suspect of common bile duct stones
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 |
|---|---|---|
| Harmonic scalpelThe Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery | Procedure or surgery | clipless |
| TraditionalThe cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips | Procedure or surgery | traditional |
Primary outcome
effectiveness closure of the cystic duct
Time frame: at 1 months
the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak
2 secondary outcomes
postoperative complication
Time frame: 1 month
efficacy and safety of the use of harmonic scalpel performing cholecystectomy
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by University of Roma La Sapienza 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness closure of the cystic duct (time frame: at 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.