Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Number of participants with vaginal stump infection in intervention group and control group
研究概览
简要总结
Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.
详细描述
Comparing two surgical techniques for vaginal stump infection after total laparoscopic or robot-assisted hysterectomy. Analysis of patient-based and therapy-based risk factors with the aim of optimizing the surgical technique and objectifying the risk factors. Control group: old colpotomy technique (3 Z-sutures PDS 0); Intervention group: new colpotomy technique (3 Z sutures with PDS 0 and 1 continuous suture with V-Loc 2-0)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient > = 18 years old
- •Indication for total laparoscopic or robot-assisted hysterectomy
- •Benign uterine disease
- •Signed informed consent for study participation
排除标准
- •Patient with malignant gynecological diseases
- •Combination with other abdominal / vaginal interventions, except:
- •Adhesiolysis
- •Endometriosis removal (without rectovaginal endometriosis)
- •Conization
- •Hysteroscopy / curettage
- •Immunosuppressive therapy with cytostatics, glucocorticoids, HIV
- •Bleeding tendency / haemophilia
- •Acute infection
研究组 & 干预措施
Arm A (test surgical technique)
Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0
干预措施: Total laparoscopic hysterectomy (Procedure)
Arm B (control surgical technique)
Colpotomy closure technique: 3 Z-suture with PDS 0
干预措施: Total laparoscopic hysterectomy (Procedure)
结局指标
主要结局
Number of participants with vaginal stump infection in intervention group and control group
时间窗: 6 weeks
7.-10. day and 6 weeks postoperatively: 1. T ° C (fever\> = 38 ° C) 2. blood pressure (mm Hg) 3. general condition (good, reduced, bad) 4. Speculum examination / condition of the colpotomy: * non-irritating / intact * dehiscent * bleeding * fibrin-coated * purulent * tender * hyperemic * Infiltrated * Fistula formation 5. Lower abdominal pain (Visual Analog Scale (VAS): 0-10 6. transvaginal sonography: encapsulated RF on vaginal stump J: ☐N: ☐ 7. Laboratory CRP (\> 10mg / L) Hb (\<120 g / L) Lc ( \>10 G / L) The diagnosis of vaginal stump infection was made based on 2 of 3 positive clinical symptoms, 1 additional criterion and the corresponding sonographic findings. I. Clinical symptoms: 1. Fever\> = 38 ° C; 2. Dolence, redness, swelling, pus in the colpotomy area; 3. Lower abdominal pain ( VAS \>5) II. Sonographic signs (TVUS): encapsulated cystic mass on the vaginal stump Additional criteria: 1. CRP increased (\> 10mg / l); 2. Antibiotic therapy needs
次要结局
- Identify of patient-based and treatment-based risk factors for vaginal stump infection.(6 weeks)
研究者
Tatiana Naydina Ragaz
Senior Gynecologist in Women's Clinic
Spital Limmattal Schlieren