Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery (CLCHS)
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ClinicalTrials.gov Identifier: NCT01139385 |
Recruitment Status
:
Completed
First Posted
: June 8, 2010
Last Update Posted
: March 17, 2015
|
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Condition or disease | Intervention/treatment |
---|---|
Cholelithiasis | Procedure: Harmonic scalpel Procedure: Traditional |
Study Type : | Observational |
Actual Enrollment : | 218 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Group/Cohort | Intervention/treatment |
---|---|
clipless
laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device
|
Procedure: Harmonic scalpel
The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery
|
traditional
laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip
|
Procedure: Traditional
The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips
|
- 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
- postoperative complication [ Time Frame: 1 month ]the presence of postoperative complication is investigated
- efficacy and safety of the use of harmonic scalpel performing cholecystectomy [ Time Frame: 24 hours ]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.

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Ages Eligible for Study: | up to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Symptomatic Cholelithiasis
- Age under 65 yr old
- BMI under 35
- ASA I or II
Exclusion Criteria:
- Acute cholecystitis
- Suspect of common bile duct stones

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139385
Italy | |
Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome | |
Rome, Italy, 00189 |
Responsible Party: | Francesco Saverio Mari, Reserch Fellows, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT01139385 History of Changes |
Other Study ID Numbers: |
DS-001 |
First Posted: | June 8, 2010 Key Record Dates |
Last Update Posted: | March 17, 2015 |
Last Verified: | December 2013 |
Additional relevant MeSH terms:
Cholelithiasis Cholecystolithiasis Gallstones Biliary Tract Diseases |
Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |