Laparoscopic versus small-incision cholecystectomy: health status in a blind randomised trial.
BACKGROUND
Gallstones are a major cause of morbidity, and cholecystectomy is a commonly performed procedure. Minimal invasive procedures, laparoscopic cholecystectomy (LC) and small-incision cholecystectomy (SIC), have replaced the classical open cholecystectomy. No differences have been found in primary outcome measures between LC and SIC, therefore secondary outcome measures have to be considered to determine preferences. The aim of our study was to examine health status applying evidence-based guidelines in LC and SIC in a randomised trial.


METHODS
Patients with symptomatic cholecystolithiasis were included in a blind randomised trial. Operative procedures, anaesthesia, analgesics and postoperative care were standardised in order to limit bias. Questionnaires were filled in preoperatively, the first day postoperatively, and at outpatients follow-up at 2, 6 and 12 weeks. In accordance with evidence-based guidelines, the generic short form (SF-36) and the disease-specific gastrointestinal quality-of-life index (GIQLI) questionnaires were used in addition to the body image questionnaire (BIQ).


RESULTS
A total of 257 patients were randomised between LC (120) and SIC (137). Analyses were performed according to intention-to-treat (converted procedures included) and also distinguishing converted from minimal invasive (nonconverted) procedures. Questionnaires were obtained with a response rate varying from 87.5% preoperatively to 77.4% three months postoperatively. Except for two time-specific measurements in one SF-36 subscale, there were no differences between LC and SIC. There were significant differences in several subscales in all three questionnaires comparing minimal invasive versus converted procedures.


CONCLUSIONS
Applying adequate methodological quality and evidence-based guidelines (by using SF-36 and GIQLI), there are no significant differences in health status between LC and SIC.
Keus
Frederik
F
Department of Surgery, Diakonessenhuis, Bosboomstraat 1, 3582, KE, Utrecht, The Netherlands. erickeus@hotmail.com
de Vries
Jolanda
J
Gooszen
Hein G
HG
van Laarhoven
Cornelis J H M
CJ
D016063:Blood Loss, Surgical / Q000706:statistics & numerical data; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects; D002763:Cholecystectomy / Q000009:adverse effects / Q000379:methods*; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects; D019317:Evidence-Based Medicine; D005260:Female; D042882:Gallstones / Q000601:surgery*; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome