Laparoscopic Hysterectomy, Vaginal Infection
Conditions
Keywords
vaginal closure technique
Brief summary
Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.
Detailed description
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)
Interventions
PROCEDURETotal laparoscopic hysterectomy
Control group: colpotomy closure technique: 3 Z-sutures PDS 0 Intervention group: colpotomy closure technique: 3 Z sutures with PDS 0 and 1 continuous suture with V-Loc 2-0
Sponsors
University of Zurich
Spital Limmattal Schlieren
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with vaginal stump infection in intervention group and control group | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify of patient-based and treatment-based risk factors for vaginal stump infection. | 6 weeks | 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 |
Countries
Switzerland
Outcome results
None listed