Laparoscopic cholecystectomy: 5-mm versus 3-mm ports

ISRCTN	ISRCTN33058794
DOI	https://doi.org/10.1186/ISRCTN33058794
Protocol serial number	lapchole3mm
Sponsor	Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Funders	Karl Storz (UK) - providing equipment, All other costs will be covered by NHS under usual treatment costs.

Submission date: 30/09/2009
Registration date: 21/07/2010
Last edited: 19/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mark Bignell
Scientific

c/o Mr Rhodes Secretary
Department of General Surgery
Norfolk and Norwich Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Study information

Primary study design	Interventional
Study design	Interventional single centre double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A prospective, randomised, double-blind trial comparing 5-mm versus 3-mm ports for laparoscopic cholecystectomy
Study objectives	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.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Symptomatic gallstone disease including pancreatitis
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Symptomatic gallstone disease 2. Age 18 to 70 years, either sex 3. Suitable for day-case procedure
Key exclusion criteria	1. Acute cholecystitis or empyema of gallbladder 2. Not fit for day-case procedure
Date of first enrolment	01/12/2009
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

c/o Mr Rhodes Secretary

Norwich
NR4 7UY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes