Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
26/01/2006
Last edited
11/01/2012
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 Cees van Laarhoven

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol 0031

Study information

Scientific title

Acronym

SILAP (Small-Incision versus LAParoscopy)

Study hypothesis

1. No difference in complications between small-incision and laparoscopic cholecystectomy
2. Difference of 10% in direct costs

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Symptomatic cholecystolithiasis

Intervention

Small-incision versus laparoscopic cholecystectomy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mortality
2. Complications
3. Costs

Secondary outcome measures

1. Pulmonary function
2. Health-related quality of life
3. Convalescence (return to work)

Overall trial start date

01/01/2001

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Two groups of 120 patients

Participant 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

Recruitment start date

01/01/2001

Recruitment end date

01/04/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Surgery
Tilburg
5022GC
Netherlands

Sponsor information

Organisation

St Elisabeth Hospital (The Netherlands)

Sponsor details

Department of Surgery
Hilvarenbeekseweg 60
Tilburg
5022GC
Netherlands

Sponsor type

University/education

Website

http://www.elisabeth.nl/

Funders

Funder type

Research organisation

Funder name

Foundation 'Gasthuisraad' (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for Scientific Research 'Midden-Brabant' (The Netherlands)

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18427025
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18071815
3. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19732431

Publication citations

  1. Results

    Keus F, Werner JE, Gooszen HG, Oostvogel HJ, van Laarhoven CJ, Randomized clinical trial of small-incision and laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis: primary and clinical outcomes., Arch Surg, 2008, 143, 4, 371-7; discussion 377-8, doi: 10.1001/archsurg.143.4.371.

  2. Results

    Keus F, de Vries J, Gooszen HG, van Laarhoven CJ, Laparoscopic versus small-incision cholecystectomy: health status in a blind randomised trial., Surg Endosc, 2008, 22, 7, 1649-1659, doi: 10.1007/s00464-007-9675-0.

  3. Protocol

    Keus F, de Jonge T, Gooszen HG, Buskens E, van Laarhoven CJ, Cost-minimization analysis in a blind randomized trial on small-incision versus laparoscopic cholecystectomy from a societal perspective: sick leave outweighs efforts in hospital savings., Trials, 2009, 10, 80, doi: 10.1186/1745-6215-10-80.

Additional files

Editorial Notes