- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01994148
Application of Laparoscopy in Gastrointestinal Injury
Study of Laparoscopy in Gastrointestinal Injury
Studieoversikt
Detaljert beskrivelse
This prospective single arm study was undertaken in West China Hospital, Sichuan University, Chengdu, China. The institution is the largest medical center in southwest China, and also a national training center of laparoscopy. Surgeons participated in the study were well trained in gastrointestinal laparoscopy and hepatobiliary laparoscopy, and were experienced in management of abdominal trauma.
The study was approved by the institutional review committees. The participants provided written informed consent.
Patients age 18 years or older with abdominal trauma were considered eligible, regardless of the nature of trauma (blunt or penetrating), but hemodynamic stability was mandatory.
Patients meet the following criteria is prepared for laparoscopic exploration:
Evidence showed that wound penetrates the peritoneum in penetrating trauma or/and signs of peritoneal irritation or positive CT scan in those without penetration of peritoneum and patients with blunt injuries.
We defined the CT scan positive by it shows peritoneal effusion, free intraperitoneal air, fat density increase, substantive organ rupture and intestinal wall swelling and other signs of abdominal trauma.
Laparoscopic screening will be performed according to protocol. The study demands that all surgeons should complete the repair laparoscopically as much as possible when condition allow, and record reasons for conversion in detail when it is inevitable.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Beijing, Kina
- Rekruttering
- Chinese PLS General Hospital
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Ta kontakt med:
- Lin Chen, MD., PhD.
- E-post: chenlinbj@vip.sina.com
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Hovedetterforsker:
- Lin Chen
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Chongqing, Kina
- Rekruttering
- Southwest Hospital, The 3rd Militory Medical University
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Ta kontakt med:
- Peiwu Yu, MD., PhD
- E-post: yupeiwu01@sina.com
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Hovedetterforsker:
- Peiwu Yu
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Shanxi
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Xian, Shanxi, Kina
- Har ikke rekruttert ennå
- Xijing Hospital, The 4th Militory Medical University
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Ta kontakt med:
- Kefeng Dou, MD., PhD
- E-post: doukef@fmmu.edu.cn
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Hovedetterforsker:
- Kefeng Dou
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University
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Ta kontakt med:
- Zongguang zhou, MD., PhD.
- Telefonnummer: 18980601007
- E-post: zhou767@163.com
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Hovedetterforsker:
- Zongguang Zhou, MD., PhD.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of gastrointestinal trauma
- Blood loss < 1000ml
- Hemodynamically stable
- Vital sign is stable
- Willing to comply to the study procedure and complete the study.
Exclusion Criteria:
- Severe hemorrhage or intraperitoneal infections
- Combined with other conditions which are contraindications to laparoscopy
- Pregnant or lactating woman
- Severe immunodeficiency
- History of drug abuse
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Laparoscopy
Laparoscopy has been increasingly applied in patients with abdominal trauma , as an diagnostic and therapeutic modality.
In this arm, we will include 100 Hemodynamically stable patients with gastrointestinal trauma, all of them will receive laparoscopic exploration,laparoscopic repair of the gastrointestinal injury will be attempted.
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In this study, laparoscopic intervention will be performed under carbon dioxide pneumoperitoneum (pressure, 10-12 mm Hg; flow volume, 8-10 L/min).
A 12-mm trocar will be placed in the umbilicus with use of an open technique and to establish pneumoperitoneum.A 10-mm and a 5-mm trocar will be inserted in the right and left flanks,respectively.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mortality
Tidsramme: 3 month after operation
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3 month after operation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Lengde på sykehusopphold
Tidsramme: 1 måned
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1 måned
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Number of iatrogenic injury during the operation
Tidsramme: at the end of the operation
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at the end of the operation
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Number of patients with postoperative complications
Tidsramme: up to 3 months
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Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula
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up to 3 months
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Operative time
Tidsramme: at the end of the operaion
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at the end of the operaion
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Blood loss during the operation
Tidsramme: at the end of the operation
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at the end of the operation
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Number of patients transferred to open operation
Tidsramme: at the end of the operation
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at the end of the operation
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Zongguang Zhou, MD., PhD, West China hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LGI-201302016
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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