This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn.

Della Badia suturing device in laparoscopic hysterectomy.

Elective treatment.

Cost-effectiveness analysis.

Patients undergoing laparoscopic hysterectomy.

Hospital. The economic study was conducted in Philadelphia, USA.

Not stated.

Effectiveness data was taken from a single study and a review of studies.

The costing was undertaken retrospectively on the same patient sample as that used in the effectiveness study.

The study sample comprised 25 patients undergoing laparoscopic hysterectomy. No power calculations relating to the sample size were stated. No further information about patient characteristics were provided. There was no control group in the study.

The study was a single centre, case-series.

The analysis of the clinical study was based on treatment completers only. The primary health outcome used in the analysis was the number of complications after the intervention. There was no discussion or adjustment for confounding variables.

In two cases, the sutures in the utero-ovarian ligament were cut and backflow bleeding developed. In a third case, a haematoma developed postoperatively. The overall complication rate was 1 in 25.

The Della Badia suturing device renders suturing simple and results in very few complications.

The outcome assessed was the complication rate of traditional laparoscopic methods.

Not stated.

Not stated.

Not stated.

Not stated.

3 studies of unspecified type were included.

Narrative method.

Not stated.

The complication rate of traditional laparoscopic methods varied between 15% and 42%.

Complication rate was used as the measure of benefit.

Direct health services costs were considered, namely acquisition costs. Costs to the patients were also considered. Quantities and costs were not reported separately. Price date was not stated.

US dollars ($).

No sensitivity analysis was performed.

In two cases, backflow bleeding developed and, in a third case, a haematoma developed postoperatively. The overall complication rate was 1 in 25.

The cost per hysterectomy was $291.92, when the Della Badia device was used, compared with $914 when using the linear stapler. The use of the same device would result in savings of $2492.28 to the patient, for each laparoscopic hysterectomy.

Incremental costs were negative, while incremental benefits were shown to be positive. The use of a Della Badia device was a dominant strategy.

In the initial 25 cases in which the Della Badia device was used, it was found to be effective and at a fraction of the cost of the linear stapler.

This paper lacks the essential ingredients of a complete cost-effectiveness study: power calculations related to the sample size, sensitivity analysis of data, assessment of patient characteristics (e.g. age, overall health status), suitable follow-up of patients.

Further research, preferably a randomised controlled trial, involving sufficient numbers of patients is required

None stated.