Vaginal Stump Infection After Laparoscopic Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2022-09-30

Brief Summary

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

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Detailed Description

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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)

Conditions

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Laparoscopic Hysterectomy Vaginal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm A (test surgical technique)

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

Group Type EXPERIMENTAL

Total laparoscopic hysterectomy

Intervention Type 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

Arm B (control surgical technique)

Colpotomy closure technique: 3 Z-suture with PDS 0

Group Type ACTIVE_COMPARATOR

Total laparoscopic hysterectomy

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No