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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (test surgical technique) | Experimental | Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0 |
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| Arm B (control surgical technique) | Active Comparator | Colpotomy closure technique: 3 Z-suture with PDS 0 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total laparoscopic hysterectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with vaginal stump infection in intervention group and control group | 7.-10. day and 6 weeks postoperatively:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
Patient with malignant gynecological diseases
Combination with other abdominal / vaginal interventions, except:
Immunosuppressive therapy with cytostatics, glucocorticoids, HIV
Bleeding tendency / haemophilia
Acute infection
All patients> 18 years of age with an indication for total laparoscopic or robot-assisted hysterectomy (with or without adnexa / tubes) for benign uterine diseases.
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana Naydina Ragaz | Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spital Limmattal | Schlieren | Canton of Zurich | 8952 | Switzerland |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |