- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03084653
Choosing the Technique for First Abdominal Entry in Laparoscopy
Choosing the Technique for First Abdominal Entry in Laparoscopy: A Questionnaire-based Observational Study.
Studieoversigt
Detaljeret beskrivelse
Several methods, i.e., the Veress needle, open approach using the Hasson trocar and direct trocar insertion without insufflation have been described for initial abdominal entry in laparoscopy. On the other hand, relatively new approaches, e.g., the optical or radially expanding trocars did not become common yet. Despite the advantages of laparoscopic surgery, serious complications can be encountered during the initial entry. Development of a complication, e.g., major vascular and intestinal injury, would affect the outcome of the operation and it may result in conversion to the open approach. Because of low incidence of these complications, it is impossible to show any superiority of one approach to another.
In this study, we aimed to analyze the rationale and the process of decision making of a surgeon about initial abdominal entry technique for laparoscopy.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ümraniye
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Istanbul, Ümraniye, Kalkun, 34000
- Umraniye Education and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- General Surgeons who approve to participate to the study will be included.
Exclusion Criteria:
- Surgical residents will be excluded from the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Survey
Close-ended survey questions were formed and will be sent to general surgeons by e-mail containing the web address of the survey.
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Close-ended survey will be performed to the participants.
The survey consisted of 18 questions (Appendix).
The first six questions (#1-6) were related with respondent's demographical and educational data and experiences of surgical and laparoscopic practices.
There were five questions to determine preferred technique for first entry (#7-11), three questions for complications (#12-14), and remaining four questions for safety maneuvers (#15-18).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rationale of choice in decision-making of first abdominal trocar entry method.
Tidsramme: through study completion, an average of 1 year
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The survey will be performed to participant general surgeons to evaluate rationale of choice in decision-making of first abdominal trocar entry method.
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through study completion, an average of 1 year
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Fatih Basak, Umraniye Education and Research Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Rationale-Trocar
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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