Laparoscopic cholecystectomy: 5-mm versus 3-mm ports

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33058794

Enrollment

100

Registered

2010-07-21

Start date

2009-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic gallstone disease including pancreatitis Digestive System Acute pancreatitis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Acute cholecystitis or empyema of gallbladder 2. Not fit for day-case procedure

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026