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| ID | Type | Description | Link |
|---|---|---|---|
| RF-2009-1535329 | Other Identifier | Ministero della Salute - Direzione Generale della Ricerca Scientifica e Tecnologica; Regione Toscana |
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| Name | Class |
|---|---|
| Regione Toscana | UNKNOWN |
| Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna | OTHER |
| Università di Pisa | UNKNOWN |
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Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional multiport laparoscopic cholecystectomy | Active Comparator | Standard laparoscopic cholecystectomy performed by the traditional multiport technique |
|
| Single port laparoscopic cholecystectomy | Experimental | Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy | Procedure | Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | 1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port | During the intervention |
| Morbidity | 1 = if the patient has surgical complications 0 = no complications | 30 days |
| Mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative course | pain, measured using 1) visual linear analogue scale and 2) analgesic administration | 1 week |
| Duration of hospital stay | Date of the operation Date of hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franco Mosca, Prof. MD | Contact | +39 (0)50 996820 | f.mosca@med.unipi.it | |
| Giovanni Caprili, MD | Contact | +39 3286875111 | mabcap@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Franco Mosca, Prof, MD | AOUP | Principal Investigator |
| Alfred Cuschieri, Prof, MD | Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Donato | Not yet recruiting | Arezzo | AR | Italy |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 6 days |
| Return of bowel function | Passage of flatus and/or bowel motion | 12, 24, 48 hours |
| Ospedale Campo di Marte | Not yet recruiting | Lucca | LU | Italy |
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| Ospedinale di Cisanello | Recruiting | Pisa | PI | 56100 | Italy |
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| Ospedale Felice Lotti | Not yet recruiting | Pontedera | PI | Italy |
|
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |