Laparoscopic cholecystectomy: 5-mm versus 3-mm ports
| ISRCTN | ISRCTN33058794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33058794 |
| Secondary identifying numbers | lapchole3mm |
- 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
Not provided at time of registration
Contact information
Mr Mark Bignell
Scientific
Scientific
c/o Mr Rhodes Secretary
Department of General Surgery
Norfolk and Norwich Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Study information
| Study design | Interventional single centre double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective, randomised, double-blind trial comparing 5-mm versus 3-mm ports for laparoscopic cholecystectomy |
| Study hypothesis | 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) |
| Condition | 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2009 |
| Overall study end date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Symptomatic gallstone disease 2. Age 18 to 70 years, either sex 3. Suitable for day-case procedure |
| Participant exclusion criteria | 1. Acute cholecystitis or empyema of gallbladder 2. Not fit for day-case procedure |
| Recruitment start date | 01/12/2009 |
| Recruitment end date | 01/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Mr Rhodes Secretary
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Kath Andrews
Research and Development Office
Level 3 East Block, Colney Lane
Norwich
NR4 7UY
England
United Kingdom
| Website | http://www.nnuh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Other
Karl Storz (UK) - providing equipment
No information available
All other costs will be covered by NHS under usual treatment costs.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
