Vaginal Stump Infection After Laparoscopic Hysterectomy

Vaginal Infection Clinical Trial

— CoToIn  

Official title:

Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04725981
• Other study ID #: BASEC-Nr.2018-00777
• Status: Terminated
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Spital Limmattal Schlieren
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.

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)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Laparoscopic Hysterectomy
• Vaginal Infection

Intervention

Procedure:
• Total 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

Locations

Country	Name	City	State
Switzerland	Spital Limmattal	Schlieren	Kanton Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Spital Limmattal Schlieren	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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