Application of Laparoscopy in Gastrointestinal Injury
Study of Laparoscopy in Gastrointestinal Injury
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing, 중국
- 모병
- Chinese PLS General Hospital
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연락하다:
- Lin Chen, MD., PhD.
- 이메일: chenlinbj@vip.sina.com
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수석 연구원:
- Lin Chen
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Chongqing, 중국
- 모병
- Southwest Hospital, The 3rd Militory Medical University
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연락하다:
- Peiwu Yu, MD., PhD
- 이메일: yupeiwu01@sina.com
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수석 연구원:
- Peiwu Yu
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Shanxi
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Xian, Shanxi, 중국
- 아직 모집하지 않음
- Xijing Hospital, The 4th Militory Medical University
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연락하다:
- Kefeng Dou, MD., PhD
- 이메일: doukef@fmmu.edu.cn
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수석 연구원:
- Kefeng Dou
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- 모병
- West China Hospital, Sichuan University
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연락하다:
- Zongguang zhou, MD., PhD.
- 전화번호: 18980601007
- 이메일: zhou767@163.com
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수석 연구원:
- Zongguang Zhou, MD., PhD.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Mortality
기간: 3 month after operation
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3 month after operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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입원 기간
기간: 1 개월
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1 개월
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Number of iatrogenic injury during the operation
기간: 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
기간: 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
기간: 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
기간: 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
기간: at the end of the operation
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at the end of the operation
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공동 작업자 및 조사자
수사관
- 연구 의자: Zongguang Zhou, MD., PhD, West China Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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