N/A
N=202
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Gallbladder Disease
Bottom Line
View on ClinicalTrials.gov: NCT00832767 ↗Enrolled (actual)
202
Serious AEs
10.0%
Results posted
Dec 2017
Primary outcome: Primary: Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC — 53; 29; 14; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SILS™ port laparoscopic cholecystectomy (Procedure); Four Port Laparoscopic Cholecystectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC |
53; 29; 14; 5; 6; 1 | — |
| PRIMARY Operative Time |
56.8; 45.3 | — |
| PRIMARY Estimated Blood Loss |
14.9; 14.1 | — |
| SECONDARY Average Pain Experienced in the Last 24 Hours at Various Time Frames |
3.1; 3.3; 6.3; 6.4; 6.7; 6.1 | — |
| SECONDARY Body Image Scale |
5.6; 5.8; 5.6; 5.8; 5.5; 5.8 | — |
| SECONDARY Cosmetic Scale |
20.5; 18.6; 21.5; 18.5; 22.1; 19.2 | — |
| SECONDARY Confidence Scale Change From Baseline |
0.5; 0.5; 0.7; 0.6; 0.5; 0.6 | — |
| SECONDARY Normalized Scar Scores |
2.8; 0.9; 3.1; 0.6; 2.5; 0.4 | — |
| SECONDARY Modified Hollander |
0.37; 0.21; 0.15; 0.06; 0.10; 0.14 | — |
| SECONDARY Physical Quality of Life |
49.1; 50.1; 31.0; 31.8; 36.8; 40.1 | — |
| SECONDARY Mental Quality of Life |
47.2; 49.1; 49.0; 50.6; 51.4; 51.3 | — |
| SECONDARY Time to Cannulization |
6.3; 6.9 | — |
Summary
The objectives of this trial are:
1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.
Eligibility Criteria
Inclusion Criteria
- Between 18 and 85 years old.
- Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF 3 with normal liver function.
- Any patient who is undergoing Peritoneal Dialysis (PD).
- Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.
Data sourced from ClinicalTrials.gov (NCT00832767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.