Vaginal Stump Infection After Laparoscopic Hysterectomy

NCT04725981 | Terminated

• 1 other identifier: BASEC-Nr.2018-00777
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laparoscopic Hysterectomy; Vaginal Infection

Keywords

vaginal closure technique

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (1)

• Identify of patient-based and treatment-based risk factors for vaginal stump infection.

  6 weeks

Study Arms (2)

Arm A (test surgical technique)

EXPERIMENTAL

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

Procedure: Total laparoscopic hysterectomy

Arm B (control surgical technique)

ACTIVE COMPARATOR

Colpotomy closure technique: 3 Z-suture with PDS 0

Procedure: Total laparoscopic hysterectomy

Interventions

Total laparoscopic hysterectomy 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 A (test surgical technique); Arm B (control surgical technique)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All patients\> 18 years of age with an indication for total laparoscopic or robot-assisted hysterectomy (with or without adnexa / tubes) for benign uterine diseases.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient \> = 18 years old
• Indication for total laparoscopic or robot-assisted hysterectomy
• Benign uterine disease
• Signed informed consent for study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Spital Limmattal Schlieren: lead
• University of Zurich: collaborator

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Tatiana Naydina Ragaz

  Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Gynecologist in Women's Clinic

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

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: January 27, 2021
• Study Start: August 23, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)