- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03084653
Choosing the Technique for First Abdominal Entry in Laparoscopy
Choosing the Technique for First Abdominal Entry in Laparoscopy: A Questionnaire-based Observational Study.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ümraniye
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Istanbul, Ümraniye, Kalkon, 34000
- Umraniye Education and Research Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Rationale of choice in decision-making of first abdominal trocar entry method.
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Fatih Basak, Umraniye Education and Research Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Rationale-Trocar
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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