Laparoscopic HysterectomyCoToInNCT04725981
Vaginal Stump Infection After Laparoscopic Hysterectomy
A study testing Total laparoscopic hysterectomy in people with Laparoscopic Hysterectomy and Vaginal Infection, run by Spital Limmattal Schlieren at 1 site in Switzerland.
Trial summary
Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy, Vaginal Infection
- What is being tested?
- Total laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Aug 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > = 18 years old
- Indication for total laparoscopic or robot-assisted hysterectomy
- Benign uterine disease
- Signed informed consent for study participation
Who cannot join
- Patient with malignant gynecological diseases
- Combination with other abdominal / vaginal interventions, except:
- Adhesiolysis
- Endometriosis removal (without rectovaginal endometriosis)
- Conization
- Hysteroscopy / curettage
Show all 9Show fewer
- Immunosuppressive therapy with cytostatics, glucocorticoids, HIV
- Bleeding tendency / haemophilia
- Acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Laparoscopic Hysterectomy, Vaginal Infection
- Being tested
- Total laparoscopic hysterectomy
- Keywords
- vaginal closure technique
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laparoscopic hysterectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A (test surgical technique) | Experimental | Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0 Receives: Procedure: Total laparoscopic hysterectomy |
| Arm B (control surgical technique) | Active comparator | Colpotomy closure technique: 3 Z-suture with PDS 0 Receives: Procedure: Total laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
Measured: 6 weeks
Secondary outcomes (1)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start23 Aug 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spital Limmattal Schlieren
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Tatiana Naydina Ragaz, Spital Limmattal Schlieren
- Investigators
- Tatiana Naydina Ragaz, Principal investigator, Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725981
- Sponsor's protocol ID
- BASEC-Nr.2018-00777
- Acronym
- CoToIn
- Status last verified
- Oct 2022
- First submitted
- 8 Dec 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Stump Infection After Total Laparoscopic or Robot-assisted Hysterectomy
- ClinicalTrials.gov ID
- NCT04725981
- Acronym / sponsor ID
- CoToIn / BASEC-Nr.2018-00777
- Conditions
- Laparoscopic Hysterectomy, Vaginal Infection
- Keywords
- vaginal closure technique
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Spital Limmattal SchlierenUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Compare two surgical techniques Prospective randomized, controlled, single-blind inversion study
| Arm | Type | Receives |
|---|---|---|
| Arm A (test surgical technique) | Experimental | Procedure: Total laparoscopic hysterectomyColpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0 |
| Arm B (control surgical technique) | Active comparator | Procedure: Total laparoscopic hysterectomyColpotomy closure technique: 3 Z-suture with PDS 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient > = 18 years old
- Indication for total laparoscopic or robot-assisted hysterectomy
- Benign uterine disease
- Signed informed consent for study participation
Key exclusion criteria (9 listed)
- Patient with malignant gynecological diseases
- Combination with other abdominal / vaginal interventions, except:
- Immunosuppressive therapy with cytostatics, glucocorticoids, HIV
- Bleeding tendency / haemophilia
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total laparoscopic hysterectomyControl 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 | Procedure or surgery | Arm A (test surgical technique), Arm B (control surgical technique) |
Primary outcome
Number of participants with vaginal stump infection in intervention group and control group
Time frame: 6 weeks
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
1 secondary outcome
Identify of patient-based and treatment-based risk factors for vaginal stump infection.
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Naydina Ragaz principal investigator
Tatiana Naydina Ragaz, Deputy Senior Gynecologist Women's Clinic, Spital Limmattal, Zurich Schlieren
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total laparoscopic hysterectomy in people with Laparoscopic Hysterectomy and Vaginal Infection, run by Spital Limmattal Schlieren at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with vaginal stump infection in intervention group and control group (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.