Vaginal Stump Infection After Laparoscopic Hysterectomy (CoToIn)

Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy

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

Study Overview

• Status: Terminated
• Conditions: Vaginal Infection; Laparoscopic Hysterectomy
• Intervention / Treatment: Procedure: Total laparoscopic hysterectomy

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)

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Kanton Zurich
    • Schlieren, Kanton Zurich, Switzerland, 8952
      • Spital Limmattal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A (test surgical technique); Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0	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
ACTIVE_COMPARATOR: Arm B (control surgical technique); Colpotomy closure technique: 3 Z-suture with PDS 0	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

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 / intactdehiscentbleedingfibrin-coatedpurulenttenderhyperemicInfiltratedFistula 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

Collaborators and Investigators

• Sponsor: Spital Limmattal Schlieren
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Tatiana Naydina Ragaz, Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2018
• Primary Completion (ACTUAL): September 30, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: vaginal closure technique
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: BASEC-Nr.2018-00777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No