Transvaginal drainage of tubo-ovarian abscess: fewer bed-days, more reinterventions

Design

Multicentre, open-label, non-inferiority randomised trial (PACTOL)

Population

208 women with tubo-ovarian abscess at 19 French hospitals (130 per protocol)

Primary outcome

Cure at 6 weeks (no reintervention, no antibiotic restart, collection resolved)

Effect

72.5% vs 77.0%; difference −4.6 points (95% CI −19.4 to 10.7)

PACTOL, published 23 September in JAMA Surgery, randomised 208 women across 19 French hospitals to ultrasound-guided transvaginal drainage or laparoscopy for tubo-ovarian abscess, alongside antibiotics. The primary outcome was cure at six weeks: no reintervention, no restart of antibiotics and resolution of the collection. The non-inferiority margin was 12.5 percentage points.

In the per-protocol analysis of 130 women, cure was 72.5% with drainage and 77.0% with laparoscopy (difference −4.6 points, 95% CI −19.4 to 10.7). Because the lower bound crossed the margin, non-inferiority was not established. Reintervention was more frequent after drainage (13.0% vs 3.3%). Hospital stay was shorter after drainage (median 2 vs 3 days), pain settled faster, and grade II or higher complications did not differ.

For a general surgeon called to a pelvic collection, this defines the conversation. Laparoscopy is more likely to be definitive; drainage is less invasive and gets women home sooner, at about a one-in-eight risk of needing another procedure. Only 130 of 208 women reached the per-protocol analysis, which weakens the precision of the estimate.

• Offer laparoscopy as the option most likely to cure tubo-ovarian abscess in one procedure.
• Offer transvaginal drainage as a less invasive alternative, telling the woman about a 13% reintervention rate.
• Expect about one day less in hospital and faster pain relief after drainage.
• Continue antibiotic therapy with either approach; evacuation does not replace it.

Why it matters

Replaces a preference-driven choice with numbers a woman can weigh herself.

Don't overread it

Failing to prove non-inferiority is not proof of inferiority, and the per-protocol population lost over a third of those randomised.

The statistics, in plain English

The trial set out to show drainage was no more than 12.5 points worse. The confidence interval stretches to 19.4 points worse, so that could not be ruled out. That is not proof drainage is inferior — it means the trial could not show it was acceptably close.

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