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The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.
Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senhance Cholecystectomy | Experimental | Cholecystectomy operation performed using Senhance robotic system |
|
| Laparoscopic Cholecystectomy | Active Comparator | Cholecystectomy operation performed using standard laparoscopic instruments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senhance Assisted Cholecystectomy | Device | Cholecystectomy performed using Senhance surgical robotic system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity Data | 30 days |
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Inclusion Criteria:
ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
Exclusion Criteria:
Patients unable tor unwilling to consent BMI >40
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Purkayastha, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College NHS Trust | London | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senhance Cholecystectomy | Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system |
| FG001 | Laparoscopic Cholecystectomy | Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Senhance Cholecystectomy | Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system |
| BG001 | Laparoscopic Cholecystectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operative Time | Posted | Median | Inter-Quartile Range | minutes | 1 day |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Senhance Cholecystectomy | Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr R Aggarwal | Imperial College London | 02033126840 | r.aggarwal@ic.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2017 | May 14, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Laparoscopic Cholecystectomy | Procedure | Standard laparoscopic cholecystectomy |
|
Cholecystectomy operation performed using standard laparoscopic instruments
Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Morbidity Data | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Laparoscopic Cholecystectomy | Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy | 0 | 20 | 0 | 20 | 5 | 20 |
| Bile leak | Hepatobiliary disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
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| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |