Randomised blind single centre study on morbidity and cost-effectiveness of two types of surgery for cholecystectomy
| ISRCTN | ISRCTN67485658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67485658 |
| Secondary identifying numbers | Protocol 0031 |
- Submission date
- 12/09/2005
- Registration date
- 26/01/2006
- Last edited
- 11/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cees van Laarhoven
Scientific
Scientific
Department of Surgery
St Elisabeth Hospital
Hilvarenbeekseweg 60
Tilburg
5022GC
Netherlands
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SILAP (Small-Incision versus LAParoscopy) |
| Study objectives | 1. No difference in complications between small-incision and laparoscopic cholecystectomy 2. Difference of 10% in direct costs |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Symptomatic cholecystolithiasis |
| Intervention | Small-incision versus laparoscopic cholecystectomy |
| Intervention type | Other |
| Primary outcome measure | 1. Mortality 2. Complications 3. Costs |
| Secondary outcome measures | 1. Pulmonary function 2. Health-related quality of life 3. Convalescence (return to work) |
| Overall study start date | 01/01/2001 |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Two groups of 120 patients |
| Key inclusion criteria | 1. Patients with symptomatic cholecystolithiasis 2. Older than 18 years 3. Reasonable to good health as classified by the American Society of Anesthesiologists (ASA) grade I - II 4. Knowledge of the Dutch language 5. Signed informed consent |
| Key exclusion criteria | 1. Choledocholithiasis 2. Cholangitis 3. Acute cholecystitis 4. Known pregnancy 5. Moderate to severe systemic disease (ASA III or higher) 6. Previous upper abdominal surgery (which would exclude the patient from laparoscopic cholecystectomy) 7. Psychiatric disease 8. History of abdominal malignancy |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/04/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Surgery
Tilburg
5022GC
Netherlands
5022GC
Netherlands
Sponsor information
St Elisabeth Hospital (The Netherlands)
University/education
University/education
Department of Surgery
Hilvarenbeekseweg 60
Tilburg
5022GC
Netherlands
| Website | http://www.elisabeth.nl/ |
|---|---|
"ROR" |
https://ror.org/04gpfvy81 |
Funders
Funder type
Research organisation
Foundation 'Gasthuisraad' (The Netherlands)
No information available
Foundation for Scientific Research 'Midden-Brabant' (The Netherlands)
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 | 01/04/2008 | Yes | No | |
| Results article | results | 01/07/2008 | Yes | No | |
| Protocol article | protocol | 04/09/2009 | Yes | No |
