- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02398110
Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy
10. august 2015 opdateret af: Xiaofeng Zou, First Affiliated Hospital of Gannan Medical University
Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial
Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking.
The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiaofeng Zou, MD
- Telefonnummer: +86-797-8269588
- E-mail: gyfyurology@126.com
Studiesteder
-
-
Jiangxi
-
Ganzhou, Jiangxi, Kina, 341000
- Rekruttering
- First Affiliated hospital of Gannan Medical University
-
Kontakt:
- Xiaofeng Zou, MD
- Telefonnummer: +86-797-8269588
- E-mail: gyfyurology@126.com
-
-
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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- female sex,
- indication for nephrectomy due to benign or malignant kidney disease,
- age between 18 and 65 years, and
- legal competence
Exclusion Criteria:
- emergency surgery,
- contraindications to laparoscopic surgery,
- class IV or V as defined by the American Society for Anesthesiologists (ASA),
- body mass index (BMI) of > 30 kg/m2,
- advanced TNM staging (≥ T3),
- history of major abdominal surgery,
- gravidity or breast-feeding, and
- no written informed consent signed
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: transvaginal NOTES nephrectomy
A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus.
A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity
|
A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus.
A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity
One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin
|
Aktiv komparator: conventional laparoscopic nephrectomy
One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin
|
A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus.
A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity
One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10)
Tidsramme: at postoperative day 1
|
Pain Scores on the Visual Analog Scale (0-10)
|
at postoperative day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cosmetic assessment (Patient Scar Assessment Questionnaire)
Tidsramme: > 3 months after surgery
|
The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ)
|
> 3 months after surgery
|
Sexual function (Female Sexual Function Index)
Tidsramme: Preoperatively, and 4, 8 and 12 months postoperatively
|
Sexual function was evaluated according to the Female Sexual Function Index
|
Preoperatively, and 4, 8 and 12 months postoperatively
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Intraoperative complications (e.g. bleeding, organ-injury)
Tidsramme: Evaluated at the operation day
|
e.g. bleeding, organ-injury
|
Evaluated at the operation day
|
Duration of the operation
Tidsramme: at the operation day
|
in minutes
|
at the operation day
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Quality of life (SF-36)
Tidsramme: on postoperative month 1
|
measured with the
|
on postoperative month 1
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Postoperative complication (classified using the Clavien-Dindo system)
Tidsramme: early (≤ 1 month), or late (>1 month)
|
Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system
|
early (≤ 1 month), or late (>1 month)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. september 2016
Studieafslutning (Forventet)
1. november 2016
Datoer for studieregistrering
Først indsendt
10. marts 2015
Først indsendt, der opfyldte QC-kriterier
19. marts 2015
Først opslået (Skøn)
25. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20121BBG70032
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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