aparoscopic cholecystectomy: 5-mm versus 3-mm ports
Completed
- Conditions
- Symptomatic gallstone disease including pancreatitisDigestive SystemAcute pancreatitis
- Registration Number
- ISRCTN33058794
- Lead Sponsor
- orfolk and Norwich University Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Symptomatic gallstone disease
2. Age 18 to 70 years, either sex
3. Suitable for day-case procedure
Exclusion Criteria
1. Acute cholecystitis or empyema of gallbladder
2. Not fit for day-case procedure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Post-operative pain, measured with the Visual Analogue Scale at 6 hours, 1 week and 6 months post-operatively<br>2. Scar cosmesis, assessed at 6 months using a validated scar questionnaire - Patient Scar Assessment Questionnaire
- Secondary Outcome Measures
Name Time Method 1. Operating time, measured in minutes and starting from the time the surgeon is ready to make the first incision until the time the dressings have been applied<br>2. Conversion to the other technique will apply in the 3-mm group only and the use of any 5-mm port to aid removal of the gallbladder will be classed as a conversion to the standard technique. Any conversions to open will also be recorded<br>3. Histology of the gallbladders, assessed from the formal histology reports and will be divided into acute cholecystitis, chronic cholecystitis, and normal gallbladder wall<br>4. Gallbladder wall thickness<br>5. Operative complications, measured immediately, and late complications will be assessed at 1 week and at 6-month follow up appointments