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
Scientific
St Antonius Hospital
Department of Surgery
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands
Study information
| Study design | A prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Early or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined cholecystolithiasis. A prospective randomised trial. |
| Study acronym | LANS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Combined cholecystolithiasis |
| Intervention | Patients will be randomised to undergo either early (within three days) or late (after 6-8 weeks) cholecystectomy |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 09/06/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 |
| Total final enrolment | 96 |
| Key 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 |
| Key exclusion criteria | 1. Biliary pancreatitis 2. Acute cholecystitis 3. American Society of Anesthesiologists (ASA) IV and V patients |
| Date of first enrolment | 09/06/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St Antonius Hospital
Nieuwegein
3430 EM
Netherlands
3430 EM
Netherlands
Sponsor information
St Antonius Hospital, Department of Surgery (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 2500
Nieuwegein
3430 EM
Netherlands
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
