- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02367703
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.
The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.
The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).
The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.
At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.
At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Clermont-Ferrand, Frankrike, 63003
- Rekruttering
- CHU de Clermont-Ferrand
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
- benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.
and
- affiliation to social security and
- informed consent
Exclusion Criteria:
- ASA III or IV patients,
- age> 80 years old,
- history of major abdominal surgery by laparotomy
- severe obesity (BMI> 35kg / m2)
- pathology of hemostasis and coagulation (liver disease, bleeding disorders)
- uterine volume estimated on preoperative ultrasonography > 300 g
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to participate.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: standard instrument
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
|
Annen: less than 3 millimeter diameter's instruments
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
operative time
Tidsramme: at day 1 (at the end of the surgery)
|
at day 1 (at the end of the surgery)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
quantity of intraoperative bleeding
Tidsramme: at day 1 (at the end of the intervention)
|
at day 1 (at the end of the intervention)
|
|
hemoglobin
Tidsramme: at day 1
|
at day 1
|
|
Pain Rating Scale (VAS)
Tidsramme: at day 1 (at 6 hours potoperative hours)
|
at day 1 (at 6 hours potoperative hours)
|
|
Pain Rating Scale (VAS)
Tidsramme: at day 1 (at 24 postoperative hours)
|
at day 1 (at 24 postoperative hours)
|
|
standard laparoscopy conversion rate
Tidsramme: at day 1
|
at day 1
|
|
postoperative complications
Tidsramme: at each additional hospitalisation
|
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
|
at each additional hospitalisation
|
Patient Scar Assessment Scale (PSAS)
Tidsramme: at 6 and 8 weeks after surgery.
|
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
|
at 6 and 8 weeks after surgery.
|
Surgen's ergonomics
Tidsramme: at the end of the surgery
|
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
|
at the end of the surgery
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Revaz BOTCHORISHVILI, CHU de Clermont-Ferrand
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHU-0223
- 2014-A01698-39 (Annen identifikator: ANSM)
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