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NCT03819309: PACTOL
Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compared With Laparoscopy
NA trial testing Ultrasound-guided transvaginal drainage in Uncomplicated Tubo Ovarian Abscess in 208 participants. Completed in 11 June 2025.
13 June 2023
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 208 |
| Start date | 30 April 2019 |
| Primary completion | 13 June 2023 |
| Estimated completion | 11 June 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Ultrasound-guided transvaginal drainage
- Laparoscopy — full drug profile →
Conditions studied
- Uncomplicated Tubo Ovarian Abscess — all drugs for Uncomplicated Tubo Ovarian Abscess →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 50, female only, with Uncomplicated Tubo Ovarian Abscess. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
"Tubo-ovarian abscess (TOA) include pyosalpinx, ovarian abscess, tubo-ovarian abscess and Douglas abscess. The only randomized study evaluating TOA treatment reported a higher cure rate (90 versus 65%) when antibiotic therapy is associated with abscess evacuation. TOA evacuation can be performed by surgery or by drainage. No studies have compared success rates between those two methods. Concerning surgery, current practices recommend performing laparoscopy which allows a shorter hospital stay, a lower complication rate and high success rates. The majority of published studies reporting radiological drainage concern ultrasound-guided transvaginal drainage. The reported success rates range from 77 to 100%. The PACTOL trial is a randomized, prospective, controlled, open, parallel, non-inferiority, multicenter trial comparing the efficacy of transvaginal drainage versus laparoscopy in both arms with antibiotic therapy in the treatment of TOA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03819309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03819309 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 8 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03819309.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing