Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 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.)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.)
时间窗: at 1 month
Clinical improvement
时间窗: at 72 hours and at 1 month
apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month
Organic improvement
时间窗: at 72 hours and at 1 month
CRP Standards and GB to 72 hours and 1 month if initially high
次要结局
- Duration of hospital stay(at day 0)
- Analgesia Type: general anesthesia versus sedation(at day 1)
- recurrent complications(at day 1)
- Operating Time(at day 1)
- Fertility prognosis by Mage score(at 3 months)
- prognosis of chronic pelvic pain score by adhesions at second look laparoscopy(at 3 months)