Vaginal Stump Infection After Laparoscopic Hysterectomy

Study Overview
=================
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)

Official Title
-----------------
Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy

Conditions
-----------------
Vaginal Infection, Laparoscopic Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Total laparoscopic hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > = 18 years old Indication for total laparoscopic or robot-assisted hysterectomy Benign uterine disease Signed informed consent for study participation Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (test surgical technique)<br>Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0 | Procedure: Total laparoscopic hysterectomy<br>* 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<br>|
| Active Comparator: Arm B (control surgical technique)<br>Colpotomy closure technique: 3 Z-suture with PDS 0 | Procedure: Total laparoscopic hysterectomy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal closure technique