Condition category
Digestive System
Date applied
30/09/2009
Date assigned
21/07/2010
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mark Bignell

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

lapchole3mm

Study information

Scientific title

A prospective, randomised, double-blind trial comparing 5-mm versus 3-mm ports for laparoscopic cholecystectomy

Acronym

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

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)

Study design

Interventional single centre double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2009

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Symptomatic gallstone disease
2. Age 18 to 70 years, either sex
3. Suitable for day-case procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

United Kingdom

Trial participating centre

c/o Mr Rhodes Secretary
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Kath Andrews
Research and Development Office
Level 3 East Block
Colney Lane
Norwich
NR4 7UY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nnuh.nhs.uk/

Funders

Funder type

Other

Funder name

Karl Storz (UK) - providing equipment

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

All other costs will be covered by NHS under usual treatment costs.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23588709

Publication citations

  1. Results

    Bignell M, Lewis MP, Cheong EC, Rhodes M, A prospective, randomized, single-blind trial of 5-mm versus 3-mm ports for laparoscopic cholecystectomy: is smaller better?, Surg Endosc, 2013, 27, 10, 3616-3621, doi: 10.1007/s00464-013-2933-4.

Additional files

Editorial Notes