- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02418052
Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE
15. april 2015 opdateret af: Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Effect of Neck Flexion on Post-operative Esophagogastric Anastomotic Leakage After Minimally Invasive Esophagectomy: a Single-center Randomized Controlled Trial
Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide.
Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC.
Gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in MIE.
However, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (CAL) in some cases.
Continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension.
In this study, the investigators attempt to adopt the maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing the incidence of CAL.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant.
The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon.
The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.
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.
Studiesteder
-
-
Chongqing
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Chongqing, Chongqing, Kina, 400042
- Rekruttering
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
-
-
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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
- Surgical resectable (T1-4a, N0-3, M0).
- Age≥18 and ≤75 years.
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2.
- Written informed consent obtain.
Exclusion Criteria:
- Carcinoma of the cervical esophagus.
- Carcinoma of the gastro-esophageal junction (GEJ).
- Prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy). -Dysfunction of cardiorespiratory system or other surgical contraindications.
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: neck flexion group
Patients who fixed in neck flexion position after MIE
|
After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant.
The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon.
The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.
|
Ingen indgriben: control group
Patients without posture intervention after MIE
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of post-operative cervical esophagogastric anastomotic leakage
Tidsramme: From the day of operation to hospital discharge (an expected average of 2 weeks)
|
The post-operative cervical esophagogastric anastomotic leakage is defined as a radiological defect at the anastomotic site, or leakage of swallowed fluid (saliva, gastric juice or food residue) out of the drain site or cervical wound.
|
From the day of operation to hospital discharge (an expected average of 2 weeks)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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. januar 2014
Primær færdiggørelse (Forventet)
1. december 2015
Studieafslutning (Forventet)
1. december 2016
Datoer for studieregistrering
Først indsendt
12. april 2015
Først indsendt, der opfyldte QC-kriterier
15. april 2015
Først opslået (Skøn)
16. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Kli2
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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