Vaginal Stump Infection After Laparoscopic Hysterectomy

Spital Limmattal Schlieren141 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

141

Conditions

Laparoscopic Hysterectomy Vaginal Infection

Interventions

Total laparoscopic hysterectomyPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Spital Limmattal

Schlieren, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Number of participants with vaginal stump infection in intervention group and control group

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

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 weeks

Data from ClinicalTrials.gov

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