Vaginal Infection Clinical Trial
— CoToInOfficial title:
Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy
Verified date | October 2022 |
Source | Spital Limmattal Schlieren |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.
Status | Terminated |
Enrollment | 141 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient > = 18 years old 2. Indication for total laparoscopic or robot-assisted hysterectomy 3. Benign uterine disease 4. Signed informed consent for study participation Exclusion Criteria: 1. Patient with malignant gynecological diseases 2. Combination with other abdominal / vaginal interventions, except: - Adhesiolysis - Endometriosis removal (without rectovaginal endometriosis) - Conization - Hysteroscopy / curettage 3. Immunosuppressive therapy with cytostatics, glucocorticoids, HIV 4. Bleeding tendency / haemophilia 5. Acute infection |
Country | Name | City | State |
---|---|---|---|
Switzerland | Spital Limmattal | Schlieren | Kanton Zurich |
Lead Sponsor | Collaborator |
---|---|
Spital Limmattal Schlieren | University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with vaginal stump infection in intervention group and control group | 7.-10. day and 6 weeks postoperatively:
T ° C (fever> = 38 ° C) blood pressure (mm Hg) general condition (good, reduced, bad) Speculum examination / condition of the colpotomy: non-irritating / intact dehiscent bleeding fibrin-coated purulent tender hyperemic Infiltrated Fistula formation Lower abdominal pain (Visual Analog Scale (VAS): 0-10 transvaginal sonography: encapsulated RF on vaginal stump J: ?N: ? 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 |
6 weeks | |
Secondary | Identify of patient-based and treatment-based risk factors for vaginal stump infection. | connection between Obesity ( BMI >30 kg/ m2), nicotine abuse ( >5 cigarettes/d), anemia ( Hb <120g/L), operation time ( >120min), uterine volume ( >100 cm3) and appearance of vaginal stump infection | 6 weeks |
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