An interventional study of Total laparoscopic hysterectomy in Laparoscopic Hysterectomy and Vaginal Infection, sponsored by Spital Limmattal Schlieren. Terminated at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Spital Limmattal Schlieren · Not applicable, Interventional, and Treatment
Comparing two surgical techniques in relation to vaginal stump infection, analysis of patient-based and therapy-based risk factors.
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)
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's enrollment of 141 is above the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →Spital Limmattal Schlieren is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Combination with other abdominal / vaginal interventions, except:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Colpotomy closure technique: 3 Z-suture with PDS 0 and 1 continuous suture with V-Loc 2-0
Procedure: Total laparoscopic hysterectomy
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
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
Time frame: 6 weeks
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
Time frame: 6 weeks
Plan to share: No
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Ran from Aug 2018 to primary completion in Sep 2022, 49 months.
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Spital Limmattal Schlieren