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Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice

18. september 2015 opdateret af: University Hospital, Clermont-Ferrand

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

Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

96

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Clermont-Ferrand, Frankrig, 63003
        • Rekruttering
        • CHU de Clermont-Ferrand

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Procedure: laparoscopic hysterectomy
Andet: 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
Procedure: laparoscopic hysterectomy

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Samarbejdspartnere

STORZ® laboratory

Efterforskere

  • Ledende efterforsker: Revaz BOTCHORISHVILI, CHU de Clermont-Ferrand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2015

Primær færdiggørelse (Forventet)

1. juni 2016

Studieafslutning (Forventet)

1. september 2016

Datoer for studieregistrering

Først indsendt

6. februar 2015

Først indsendt, der opfyldte QC-kriterier

19. februar 2015

Først opslået (Skøn)

20. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHU-0223
  • 2014-A01698-39 (Anden identifikator: ANSM)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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