Early or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined cholecystolithiasis. A prospective randomised trial.

ISRCTN ISRCTN42981144
DOI https://doi.org/10.1186/ISRCTN42981144
Secondary identifying numbers NL649, NTR710
Submission date
21/07/2006
Registration date
21/07/2006
Last edited
08/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D. Boerma
Scientific

St Antonius Hospital
Department of Surgery
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands

Study information

Study designA prospective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEarly or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined cholecystolithiasis. A prospective randomised trial.
Study acronymLANS
Study objectivesEarly 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCombined cholecystolithiasis
InterventionPatients will be randomised to undergo either early (within three days) or late (after 6-8 weeks) cholecystectomy
Intervention typeOther
Primary outcome measureNumber of conversions to open cholecystectomy
Secondary outcome measures1. Length of operation
2. Postoperative pain and performance scale
3. Complications of cholecystectomy
4. Hospital stay
5. Time until professional rehabilitation
Overall study start date09/06/2006
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants96
Total final enrolment96
Key inclusion criteria1. 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
Key exclusion criteria1. Biliary pancreatitis
2. Acute cholecystitis
3. American Society of Anesthesiologists (ASA) IV and V patients
Date of first enrolment09/06/2006
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

St Antonius Hospital
Nieuwegein
3430 EM
Netherlands

Sponsor information

St Antonius Hospital, Department of Surgery (The Netherlands)
Hospital/treatment centre

P.O. Box 2500
Nieuwegein
3430 EM
Netherlands

ROR logo "ROR" https://ror.org/01jvpb595

Funders

Funder type

Hospital/treatment centre

St Antonius Hospital, Nieuwegein

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2010 08/01/2021 Yes No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.