Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LANS
Study hypothesis
Early laparoscopic cholecystectomy after endoscopic sphincterotomy for combined cholecystolithiasis, leads to less conversions as compared to laparoscopic cholecystectomy 6-8 weeks after sphincterotomy, and thus reduces morbidity and hospital stay.
Ethics approval
Not provided at time of registration
Study design
A prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Combined cholecystolithiasis
Intervention
Patients will be randomised to undergo either early (within three days) or late (after 6-8 weeks) cholecystectomy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of conversions to open cholecystectomy
Secondary outcome measures
1. Length of operation
2. Postoperative pain and performance scale
3. Complications of cholecystectomy
4. Hospital stay
5. Time until professional rehabilitation
Overall trial start date
09/06/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Proven common bile duct (CBD) stones
2. Proven gallbladder stones
3. Successful sphincterotomy and stone extraction
4. Patients older than 18 years of age
5. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
96
Participant exclusion criteria
1. Biliary pancreatitis
2. Acute cholecystitis
3. American Society of Anesthesiologists (ASA) IV and V patients
Recruitment start date
09/06/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
St Antonius Hospital
Nieuwegein
3430 EM
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
St Antonius Hospital, Nieuwegein
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