Application of Laparoscopy in Gastrointestinal Injury
Study of Laparoscopy in Gastrointestinal Injury
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Beijing, Kina
- Rekrytering
- Chinese PLS General Hospital
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Kontakt:
- Lin Chen, MD., PhD.
- E-post: chenlinbj@vip.sina.com
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Huvudutredare:
- Lin Chen
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Chongqing, Kina
- Rekrytering
- Southwest Hospital, The 3rd Militory Medical University
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Kontakt:
- Peiwu Yu, MD., PhD
- E-post: yupeiwu01@sina.com
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Huvudutredare:
- Peiwu Yu
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Shanxi
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Xian, Shanxi, Kina
- Har inte rekryterat ännu
- Xijing Hospital, The 4th Militory Medical University
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Kontakt:
- Kefeng Dou, MD., PhD
- E-post: doukef@fmmu.edu.cn
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Huvudutredare:
- Kefeng Dou
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Rekrytering
- West China Hospital, Sichuan University
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Kontakt:
- Zongguang zhou, MD., PhD.
- Telefonnummer: 18980601007
- E-post: zhou767@163.com
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Huvudutredare:
- Zongguang Zhou, MD., PhD.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Mortality
Tidsram: 3 month after operation
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3 month after operation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Längden på sjukhusvistelsen
Tidsram: 1 månad
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1 månad
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Number of iatrogenic injury during the operation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: at the end of the operation
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at the end of the operation
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Zongguang Zhou, MD., PhD, West China Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LGI-201302016
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