search
Back to results

Vaginal Stump Infection After Laparoscopic Hysterectomy (CoToIn)

Primary Purpose

Laparoscopic Hysterectomy, Vaginal Infection

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Total laparoscopic hysterectomy
Sponsored by
Spital Limmattal Schlieren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Hysterectomy focused on measuring vaginal closure technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Spital Limmattal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (test surgical technique)

Arm B (control surgical technique)

Arm Description

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

Colpotomy closure technique: 3 Z-suture with PDS 0

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2020
Last Updated
October 11, 2022
Sponsor
Spital Limmattal Schlieren
Collaborators
University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT04725981
Brief Title
Vaginal Stump Infection After Laparoscopic Hysterectomy
Acronym
CoToIn
Official Title
Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spital Limmattal Schlieren
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Hysterectomy, Vaginal Infection
Keywords
vaginal closure technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
Masking
Participant
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (test surgical technique)
Arm Type
Experimental
Arm Description
Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0
Arm Title
Arm B (control surgical technique)
Arm Type
Active Comparator
Arm Description
Colpotomy closure technique: 3 Z-suture with PDS 0
Intervention Type
Procedure
Intervention Name(s)
Total laparoscopic hysterectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with vaginal stump infection in intervention group and control group
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Identify of patient-based and treatment-based risk factors for vaginal stump infection.
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient > = 18 years old Indication for total laparoscopic or robot-assisted hysterectomy Benign uterine disease Signed informed consent for study participation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Naydina Ragaz
Organizational Affiliation
Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spital Limmattal
City
Schlieren
State/Province
Kanton Zurich
ZIP/Postal Code
8952
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vaginal Stump Infection After Laparoscopic Hysterectomy

We'll reach out to this number within 24 hrs