- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03016026
Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy
Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
Studieoversigt
Detaljeret beskrivelse
Preoperative education about ERAS program is administered in the ward after admission by a specific team. Breathing training and atomizing during the time of preoperative preparation is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10% carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation is not recommended as routine procedure.
The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns of surgical safety). Surgical site infiltration is implemented.All patients undergo laparoscopic distal gastrectomy.
Urinary catheters are routinely removed within 24 hours after operation. An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on POD 4. Abdominal drains are routinely removed within 72 hours after operation.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510-515
- Rekruttering
- Nanfang Hospital, Southern Medical University
-
Kontakt:
- Yu Zhu, M.D.
- Telefonnummer: +86-135-6022-0055
- E-mail: 283934099@qq.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- no severe organ dysfunction
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I or II
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: ERAS
Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.
|
Undergo an ERAS program
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postoperative hospital stays
Tidsramme: 1 month
|
Days from surgery to discharge
|
1 month
|
Rehabilitative rate
Tidsramme: 4 days
|
Postoperative 4 days
|
4 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Medical cost
Tidsramme: 1 month
|
From surgery to discharge
|
1 month
|
Postoperative pain score
Tidsramme: 4 days
|
Postoperative 4 days
|
4 days
|
Postoperative recovery index
Tidsramme: 1 month
|
1 month
|
|
Postoperative inflammatory immune response
Tidsramme: 4 days
|
Postoperative 4 days
|
4 days
|
Morbidity rates
Tidsramme: 30 days
|
30 days
|
|
Mortality rates
Tidsramme: 30 days
|
30 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Guoxin Li, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Ledende efterforsker: Kexuan Liu, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Studieleder: Hao Liu, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Studieleder: Li Zhen, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Studieleder: Xiaomin Hou, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Studieleder: Jiang Yu, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Studieleder: Yu Zhu, MD., MD.,Ph.D
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ERAS-LAG-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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 .
Kliniske forsøg med Neoplasmer i maven
-
Guangzhou First People's HospitalAfsluttet
Kliniske forsøg med ERAS
-
Acotec Scientific Co., LtdZhejiang UniversityAfsluttetÅreknuder i underekstremiteterneKina
-
IgenomixUkendtGentagen implantationsfejlSpanien
-
Peking University Third HospitalRenJi Hospital; Northwest Women's and Children's Hospital, Xi'an, ShaanxiRekrutteringInfertilitet, kvinde | IVF/ICSIKina
-
IgenomixAfsluttetInfertilitet af livmoderoprindelseForenede Stater, Argentina, Brasilien, Canada, Chile, Georgien, Indien, Mexico, Spanien, Taiwan, Kalkun, Vietnam
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)UkendtBrystkræftForenede Stater
-
Shady Grove Fertility Reproductive Science CenterIgenomixUkendtInfertilitet, kvinde | ImplantationsfejlForenede Stater
-
Stanford UniversityInstituto Valenciano de Infertilidad, IVI VALENCIAAfsluttetUforklarlig infertilitet | Gentagende graviditetstabForenede Stater
-
Eli Lilly and CompanyAfsluttetHypertension, lungeSpanien, Polen, Belgien, Tyskland, Holland, Forenede Stater, Japan, Brasilien, Israel, Italien, Østrig, Kalkun, Frankrig, Mexico
-
Amsterdam UMC, location VUmcUkendtPulmonal arteriel hypertensionHolland
-
United TherapeuticsAfsluttetPulmonal arteriel hypertensionForenede Stater