- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02777034
Laparoscopy Combined With Enhanced Recovery Pathway
Short-Term Outcomes of Laparoscopy Combined With Enhanced Recovery Pathway After Ileocolon Resection for Crohn's Disease
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jianjian Xiang, doctor
- Telefonnummer: 008613588706479
- E-mail: nuzwlvran@163.com
Undersøgelse Kontakt Backup
- Navn: Xiang
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Rekruttering
- Sir Run Run Shaw Hospital
-
Kontakt:
- Jianjian Xiang, doctor
- Telefonnummer: 008615168326849
- E-mail: ybxjj1990@126.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven CD with disease localized to the terminal ileum with or without ascending colon involvement.
Exclusion Criteria:
- Those patients were excluded:previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Enhanced Recovery
Preoperative protocols:Multidisciplinary patient information、no bowel preparation、no fasting(drink 10% glucose 1000 at 21:30 night before the surgery). Intraoperative protocols:Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains. Postoperative protocols:no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management(<2000ml/d). |
Preoperative protocols:Multidisciplinary patient information、no bowel preparation、no fasting(drink 10% glucose 1000 at 21:30 night before the surgery). Intraoperative protocols:Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains. Postoperative protocols:no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management(<2000ml/d).
Andre navne:
|
Andet: Unenhanced Recovery
Preoperative protocols:Patient information、Mechanical bowel preparation、Fasting since midnight before operation. Intraoperative protocols:Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains. Postoperative protocols:no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management(>2000ml/d). |
Preoperative protocols:Patient information、Mechanical bowel preparation、Fasting since midnight before operation. Intraoperative protocols:Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains. Postoperative protocols:no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management(>2000ml/d).
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The time of Flatus and Defecation
Tidsramme: 0-10 days
|
0-10 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The time of liquid diet and semiliquid diet
Tidsramme: 0-10 days
|
0-10 days
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Postoperative complications
Tidsramme: 0-10 days
|
0-10 days
|
Postoperative hospitalization cost
Tidsramme: 0-10 days
|
0-10 days
|
Hospital readmission rates
Tidsramme: 0-30 days after discharge
|
0-30 days after discharge
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Wei Zhou, Doctor, Sir Run Run Shaw Hospital
Publikationer og nyttige links
Generelle publikationer
- Spinelli A, Bazzi P, Sacchi M, Danese S, Fiorino G, Malesci A, Gentilini L, Poggioli G, Montorsi M. Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis. J Gastrointest Surg. 2013 Jan;17(1):126-32; discussion p.132. doi: 10.1007/s11605-012-2012-5. Epub 2012 Sep 5.
- Andersen J, Kehlet H. Fast track open ileo-colic resections for Crohn's disease. Colorectal Dis. 2005 Jul;7(4):394-7. doi: 10.1111/j.1463-1318.2005.00788.x.
- Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.
- Zhu Y, Xiang J, Liu W, Cao Q, Zhou W. Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study. Gastroenterol Res Pract. 2018 Nov 11;2018:9648674. doi: 10.1155/2018/9648674. eCollection 2018.
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
- SRRSH20160427-001
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 Crohns sygdom
-
Asan Medical CenterIkke rekrutterer endnuCrohns sygdom | Terapeutisk lægemiddelovervågning | Infliximab | Perianal fistel på grund af Crohns sygdom | Magnetic Resonance Novel Index for Fistel Imaging i Crohn's Disease Score