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ISRCTN
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ISRCTN33058794
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ClinicalTrials.gov identifier
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Public title
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Laparoscopic cholecystectomy: 5-mm versus 3-mm ports
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Scientific title
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A prospective, randomised, double-blind trial comparing 5-mm versus 3-mm ports for laparoscopic cholecystectomy
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Acronym
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N/A
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Serial number at source
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lapchole3mm
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Study hypothesis
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The principal research question is to see if there is any benefit in terms of post-operative pain and cosmetic outcome following laparoscopic cholecystectomy when the ports are reduced in size from 5-mm to 3-mm whilst evaluating the 5-mm technique for patient satisfaction.
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Lay summary
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Ethics approval
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Submitted to Cambridgeshire 4 Research Ethics Committee (REC) on the 5th October 2009, review taking place on the 22nd October 2009 (ref: 09/H0305/96)
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Study design
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Interventional single centre double blind randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Symptomatic gallstone disease including pancreatitis
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Participants - inclusion criteria
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1. Symptomatic gallstone disease
2. Age 18 to 70 years, either sex
3. Suitable for day-case procedure
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Participants - exclusion criteria
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1. Acute cholecystitis or empyema of gallbladder
2. Not fit for day-case procedure
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Anticipated start date
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01/12/2009
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Anticipated end date
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01/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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Patients will be randomised to the standard '5-mm' laparoscopic cholecystectomy or the '3-mm' laparoscopic cholecystectomy. The difference between the two being the epigastric and right upper quadrant ports. The umbilical port is 10-mm in size in both cases.
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Primary outcome measure(s)
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1. Post-operative pain, measured with the Visual Analogue Scale at 6 hours, 1 week and 6 months post-operatively
2. Scar cosmesis, assessed at 6 months using a validated scar questionnaire - Patient Scar Assessment Questionnaire
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Secondary outcome measure(s)
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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
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
3. Histology of the gallbladders, assessed from the formal histology reports and will be divided into acute cholecystitis, chronic cholecystitis, and normal gallbladder wall
4. Gallbladder wall thickness
5. Operative complications, measured immediately, and late complications will be assessed at 1 week and at 6-month follow up appointments
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Sources of funding
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Karl Storz (UK) - providing equipment
All other costs will be covered by NHS under usual treatment costs.
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Trial website
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Publications
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Contact name
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Mr
Mark
Bignell
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Address
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c/o Mr Rhodes Secretary
Department of General Surgery
Norfolk and Norwich Hospital
Colney Lane
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Sponsor
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Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
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Address
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c/o Kath Andrews
Research and Development Office
Level 3 East Block, Colney Lane
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Sponsor website:
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http://www.nnuh.nhs.uk/
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Date applied
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30/09/2009
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Last edited
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21/07/2010
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Date ISRCTN assigned
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21/07/2010
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