Drainage of Tubo - Ovarian Abscess: DTOA
Tubo-ovarian Abscess
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 43 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- No aceptados
- Participantes
- 80 Real
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Acerca de la investigación
The treatment of the acute phase of the complicated abscess tubo-ovarian relies on antibiotics more or less associated with surgical management in case of visible abscess, poor clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF recommended in 2012 that the tubo-ovarian abscess are not within one antibiotic, and should be drained by interventional radiology, preferably by transvaginal or laparoscopic.
Furthermore the efficiency of drainage by ultrasound puncture performed vaginally was demonstrated. This approach tends to replace the first laparoscopy because of its less invasive, fast, easy to access, more acceptable and less cost compared to laparoscopy. This approach is recommended by the French and English colleges.
In total, the surgery in case of ATO is necessary, it is always coupled with antibiotics. Several surgical approaches are possible, laparotomy, laparoscopy and ultrasound-guided puncture. No prospective comparative study has been done, for which we want to develop this study.
Leer la descripción completa
Retrospective studies evaluating the efficacy of these two supported relate the same cure rates between the two techniques. According to the literature of Garbin O.and al in 2012, the success rate of transvaginal puncture is generally 93.6%. The largest series of Gjelland al in 2005 and covers 302 consecutive patients with ATO who underwent triple antibiotic therapy and transvaginal puncture, the success rate was 93.4%. The failures that required surgical management have frequently revealed endometriosis or cancer. To support laparoscopic, Raiga and al in 1996 studied the support of 36 retrospectively patients who underwent laparoscopic incisional and wash the abscess with a success rate of 100%. Moreover Reich and al in 1987 found 90% success on a review of 25 patients.
The transvaginal echo guided puncture to replace the first laparoscopy because of its less invasive nature, this is a simple act, fast, possible under mild sedation, the cost is still lower than laparoscopy. Some uncontrolled retrospective studies suggest that laparoscopy remains associated with prolongation of hospitalization time, it is also mentioned that the transvaginal puncture is better tolerated by the patient.
No study has compared these two techniques, which is why we propose this study.
¿Quién podría participar?
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Inclusion Criteria:
- Patients with a IGH with tubo-ovarian abscess visible on ultrasound or CT
- Ultrasound abscess\> or equal to 2cm
- Abdominal pain syndrome
- Age 18 to 43 years
- understand french language
- No complicated: good hemodynamic tolerance, not broken
- These patients should be affiliated to the French Social Security and must have given informed participation agreement
Exclusion Criteria:
Patients with HIV (CD4 \<200) or co-infections: immunosuppression
- Multi-Abdomen surgery
- Suspected malignant or borderline tumor
- Complicated abscess: rupture of the abscess, peritonitis, septic shock
- Postoperative pelvic abscess
- Patient minor
- During Pregnancy
- Patient having already been accounted for tubo-ovarian abscess in progress
- Not accessible abscess transvaginal puncture
- Patients unable major, patients suffering from mental pathology incompatible with informed consent, refusal to participate
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
laparoscopy
the tubo-ovarian abscess should be drained by interventional radiology, preferably by transvaginal or laparoscopic
Procedure: laparoscopic approach
ultrasound-guided puncture
The transvaginal echo guided puncture to replace the first laparoscopy because of its less invasive nature, this is a simple act, fast, possible under mild sedation, the cost is still lower than laparoscopy
Procedure: transvaginal approach
transvaginal approach PROCEDURE
No informado en este registro.
laparoscopic approach PROCEDURE
No informado en este registro.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Clinical cure rate defined by a composite score as defined by O'Brien PC (Procedures for Comparing samples with multiple endpoints Biometrics 1984; 40: 1079-1087.)
Plazo: at 72 hour
No informado en este registro.
Clinical cure rate defined by a composite score as defined by O'Brien PC (Procedures for Comparing samples with multiple endpoints Biometrics 1984; 40: 1079-1087.)
Plazo: at 1 month
No informado en este registro.
Clinical improvement
Plazo: at 72 hours and at 1 month
apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month
Organic improvement
Plazo: at 72 hours and at 1 month
CRP Standards and GB to 72 hours and 1 month if initially high
Medidas secundarias
Duration of hospital stay
Plazo: at day 0
No informado en este registro.
Analgesia Type: general anesthesia versus sedation
Plazo: at day 1
No informado en este registro.
recurrent complications
Plazo: at day 1
Per Statement of complications and postoperative and rehospitalization
Operating Time
Plazo: at day 1
No informado en este registro.
Fertility prognosis by Mage score
Plazo: at 3 months
No informado en este registro.
prognosis of chronic pelvic pain score by adhesions at second look laparoscopy
Plazo: at 3 months
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
CHU Clermont-FerrandClermont-Ferrand, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- University Hospital, Clermont-Ferrand
- Inicio del estudio
- 26 oct 2016 Real
- Finalización primaria
- 4 feb 2022 Real
- Finalización del estudio
- 4 sept 2022 Real
- Primera publicación
- 25 may 2017 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026