Vaginal Stump Infection After Laparoscopic Hysterectomy (CoToIn)

Spital Limmattal Schlieren

Status: Terminated

Conditions: Laparoscopic Hysterectomy; Vaginal Infection

Treatments: Procedure: Total laparoscopic hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04725981

BASEC-Nr.2018-00777

Details and patient eligibility

About

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

Full 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)

Enrollment: 141 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 2 patient groups

Arm A (test surgical technique)

Experimental group

Description:

Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0

Treatment:

Procedure: Total laparoscopic hysterectomy

Arm B (control surgical technique)

Active Comparator group

Description:

Colpotomy closure technique: 3 Z-suture with PDS 0

Treatment:

Procedure: Total laparoscopic hysterectomy