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
Protocol serial number	Protocol 0031
Sponsor	St Elisabeth Hospital (The Netherlands)
Funders	Foundation 'Gasthuisraad' (The Netherlands), Foundation for Scientific Research 'Midden-Brabant' (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Cees van Laarhoven
Scientific

Department of Surgery
St Elisabeth Hospital
Hilvarenbeekseweg 60
Tilburg
5022GC
Netherlands

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Mortality 2. Complications 3. Costs
Key secondary outcome measure(s)	1. Pulmonary function 2. Health-related quality of life 3. Convalescence (return to work)
Completion date	01/04/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
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

Department of Surgery

Tilburg
5022GC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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