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This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single port laparoscopic device |
|
| 2 | Active Comparator | Four-port laparoscopic device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy surgery | Device | Single port laparoscopic cholecystectomy surgery versus a standard four port device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. | 3-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy. | 3-6 weeks |
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Inclusion Criteria:
Pre-operative diagnosis of one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul D Hansen, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21494123 | Derived | Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy. Ann Surg. 2011 Jul;254(1):22-7. doi: 10.1097/SLA.0b013e3182192f89. |
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