JOURNAL REPORTCHOLELITHIASIS

PGI Alexander L. Gonzales IIDOH – PCSCH 2012

Feasibility of minilaparotomy versus laparoscopic

cholecystectomy for day surgery: a prospective

randomised study

J. Harju1, H. Kokki2, M. Pääkkönen3, K. Karjalainen4, M. Eskelinen3 Department of Surgery, Helsinki University Central Hospital, Helsinki, Finland

Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland

Department of Surgery, Kuopio University Hospital, Kuopio, FinlandKuusankoski District Hospital, Kouvola, Finland

Scandinavian Journal of Surgery 99: 132–136, 2010

OBJECTIVE

• To evaluate the efficacy and success of both minilaparotomy and laparoscopic cholecystectomy in day (outpatient) surgery

BACKGROUND

• Minilaparotomy (MC ) and laparoscopic cholecystectomy (LC ) are commonly applied surgical techniques in the management of symptomatic gallstone disease.

• Both techniques are used in day surgery patients, but to our knowledge MC and LC have not been compared in randomised trials as day surgery procedures.

MATERIALS and METHODS

RESULTS

• The success rate as a day surgery for MC was 66% (19/29) and that for LC 55% (17/31) with no difference between the two groups.

• Three patients developed superficial infection (two with MC and one with LC ).

• One patient with conversion in the LC -group developed a common bile duct stricture and was readmitted at the 10th postoperative day.

RESULTS

DISCUSSION

• Both MC and LC are feasible surgical techniques for day surgery.

• However, appropriate prevention and prompt management of established postoperative nausea and vomiting and careful patient selection are important aspects for success of shortstay approach.

• If there is a sign of chronic cholecystitis preoperatively, it might be considered as a contraindication for day surgery.

CRITICAL APPRAISAL

RelevanceIs the objective of the article comparing therapeutic

interventions similar to your clinical dilemma?

• Yes. The objective of the study was to assess and compare the outcome of minilaparotomy and laparoscopic cholecystectomy in the management of cholelithiasis

• Population: patients with uncomplicated cholelithiasis

• Intervention: surgical treatment• Outcome: success in surgery and improvement

in quality of life

Validity Guides

Was the assignment of patients to treatment randomized?

• Yes. The present study was randomised and prospective with two parallel groups.

• The computer generated randomisation was concealed with the sealed envelope method until the patient enrolment, after randomisation the study was open.

Validity Guides

Were all patients who entered the trial properly accounted for and attributed at its conclusion? Was follow up complete?

• 60 consecutive patients with symptomatic noncomplicated gallstone disease were randomised to undergo either MC (n = 29) or LC (n = 31).

• The patients’ outcome was recorded up to four weeks after the operation

Validity Guides

Were patients analyzed in the groups to which they were randomized?

• Patients were analyzed according to the intervention that they received:– 29 underwent MC and 18 LC at the Kuusankoski

District Hospital,– 9 had MC and 13 LC at the Kuopio University

Hospital

Validity Guides

Were patients, their clinicians, and study personnel “blind” to treatment?

• Allocation of patients to treatment groups were carried out by an investigator who was blinded for the treatment assignment of the patients and also for the post- or pretreatment status.

Validity Guides

Were the groups treated equally, apart from the experimental therapy?

• Yes. There were no other interventions applied to the patients stated in the study other than their designated therapeutic interventions.

Validity Guides

Were the groups similar at the start of the trial?

• There were no significant differences in any of the parameters between the treatment groups.

Overall, is the study valid?

• Yes. Overall the study is valid because the majority of the validity guidelines were met.

THANK YOU!