Transvaginal Drainage vs Laparoscopy for Tubo-Ovarian Abscess: A Randomized Clinical Trial

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Abstract

IMPORTANCE: The treatment of tubo-ovarian abscess involves a combination of antibiotic therapy and abscess evacuation, which is usually performed by transvaginal drainage or laparoscopy. OBJECTIVE: To demonstrate noninferiority of transvaginal drainage compared with laparoscopy for treatment of tubo-ovarian abscess in terms of the cure rate. DESIGN, SETTING, AND PARTICIPANTS: The PACTOL (Efficacité de la Ponction transvaginale pour le traitement des AbCès Tubo-Ovariens par rapport à la Laparoscopie) multicenter, randomized, controlled, open, noninferiority clinical trial included patients aged 18 years or older and planning to undergo tubo-ovarian abscess evacuation who were recruited from 19 French hospitals and randomized between April 30, 2019, and April 29, 2023, with a 6-week follow-up duration. Data analysis was conducted from April 2024 to May 2025. INTERVENTION: Ultrasound-guided transvaginal drainage or laparoscopy. MAIN OUTCOMES AND MEASURES: The primary outcome was the cure rate, defined using a composite criterion, evaluated at 6 weeks after tubo-ovarian abscess evacuation. The criteria were (1) no surgical reintervention, (2) no reintroduction of antibiotic therapy, and (3) disappearance of the tubo-ovarian collection. Noninferiority was defined as a difference of 12.5 percentage points or less for the main outcome. RESULTS: Among the 208 patients included (mean [SD] age, 34.7 [8.8]; all female), 130 were included in the per-protocol analysis. Six weeks after evacuation, 50 of 69 patients (72.5%) in the transvaginal drainage group and 47 of 61 patients (77.0%) in the laparoscopy group achieved the primary outcome (difference, -4.6 percentage points [95% CI, -19.4 to 10.7 percentage points]). There were no differences in persistence of the tubo-ovarian collection and reintroduction of antibiotic therapy. Reintervention was more frequently necessary in the transvaginal drainage group than in the laparoscopy group (9 of 69 patients [13.0%] vs 2 of 61 patients [3.3%], respectively; P = .046). In the intention-to-treat population, 201 women were included. The duration of hospitalization was significantly longer for laparoscopy than for transvaginal drainage (median [IQR], 3 [2-4] vs 2 [2-3] days, respectively; P = .01). The rates of Clavien-Dindo surgical complications of grade II or higher did not differ between groups. The pain score after tubo-ovarian abscess evacuation decreased more quickly in the transvaginal drainage group. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the noninferiority of transvaginal drainage compared with laparoscopy for tubo-ovarian abscess evacuation was not established, and transvaginal drainage required reintervention more frequently than laparoscopy. Considering the less invasive nature of transvaginal drainage, this approach should be offered as an alternate to laparoscopy, although patients should be aware that it has a higher probability of reintervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03819309.

Abstract as published, via PubMed.