Condition category
Urological and Genital Diseases
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
26/07/2006
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

Dr D. Boerma

ORCID ID

Contact details

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

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

Sponsor information

Organisation

St Antonius Hospital, Department of Surgery (The Netherlands)

Sponsor details

P.O. Box 2500
Nieuwegein
3430 EM
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes