- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04240730
Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer
7. februar 2020 opdateret af: Emre Mat, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
6
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kartal
-
Istanbul, Kartal, Kalkun, 34890
- University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital
-
-
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Extreme obese patients with early stage type-1 endometrial cancer
Beskrivelse
Inclusion Criteria:
- Extreme obese patients
- Early stage type-1 endometrial cancer proved by endometrial sampling
Exclusion Criteria:
- any contraindication for pneumoperitoneum
- any contraindication for the dorsal lithotomy position
- any contraindication for general anesthesia,
- any contraindication for v-NOTES
- suspicion of pelvic adhesions
- presence or suspicion of obliteration of the pouch of Douglas
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
extremely obese patients with early-stage endometrial cancer
|
Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Operating time
Tidsramme: 4 hours
|
The operation time in minutes.
The operation time was from commencement of the colpotomy incision to vaginal closure.
|
4 hours
|
Any conversion to conventional laparoscopy or laparotomy
Tidsramme: 4 hours
|
Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.
|
4 hours
|
Pre- and post-operative hemoglobin levels
Tidsramme: 24 hours
|
Hemoglobin levels in g/dL.
Hemoglobin levels of the patients before surgery and on postoperative day 1.
|
24 hours
|
Length of hospital stay
Tidsramme: 2 day
|
Length of hospital stay in days.
Duration of hospital stay was calculated from the patient's admission until hospital discharge.
|
2 day
|
Any intra- or post-operative complication
Tidsramme: 6 months
|
Number of the patients who have any complication during or after transvaginal natural orifice surgery.
|
6 months
|
pain scores
Tidsramme: 6 hours
|
Pain scores in VAS score.
Pain scores were evaluated using a visual analog scale (VAS).
Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
|
6 hours
|
pain scores
Tidsramme: 12 hours
|
Pain scores in VAS score.
Pain scores were evaluated using a visual analog scale (VAS).
Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
|
12 hours
|
pain scores
Tidsramme: 24 hours
|
Pain scores in VAS score.
Pain scores were evaluated using a visual analog scale (VAS).
Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
|
24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Ahmet Kale, Prof.Dr., Kartal Dr.Lutfi Kirdar Research and Training Hospital
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 (Faktiske)
1. januar 2019
Primær færdiggørelse (Faktiske)
30. juni 2019
Studieafslutning (Faktiske)
30. juni 2019
Datoer for studieregistrering
Først indsendt
22. januar 2020
Først indsendt, der opfyldte QC-kriterier
22. januar 2020
Først opslået (Faktiske)
27. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- v-NOTESandobesity
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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