Application of Laparoscopy in Gastrointestinal Injury

NCT01994148 | Unknown

• 1 other identifier: LGI-201302016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

laparoscopy has been increasingly applied in patients with abdominal trauma , as an diagnostic and therapeutic modality. However, its clinical benefits are still under evaluation. The aim of this study is to prospectively assess the feasibility and safety of this technique in the management of traumatic gastrointestinal injury.

Conditions

Gastrointestinal Injury

Keywords

Trauma; Gastrointestinal injury; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Mortality

  3 month after operation

Secondary Outcomes (6)

• Number of iatrogenic injury during the operation

  at the end of the operation

• Number of patients with postoperative complications

  up to 3 months

• Operative time

  at the end of the operaion

• Blood loss during the operation

  at the end of the operation

• Length of hospital stay

  1 month

Study Arms (1)

Laparoscopy

EXPERIMENTAL

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.

Procedure: Laparoscopy

Interventions

Laparoscopy PROCEDURE

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.

Laparoscopy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Severe hemorrhage or intraperitoneal infections
• Combined with other conditions which are contraindications to laparoscopy
• Pregnant or lactating woman
• Severe immunodeficiency
• History of drug abuse

Sponsors & Collaborators

• Prof. Zongguang Zhou: lead

Study Sites (4)

Xijing Hospital, The 4th Militory Medical University

Xian, Shanxi, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Chinese PLS General Hospital

Beijing, China

RECRUITING

Southwest Hospital, The 3rd Militory Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zongguang Zhou, MD., PhD

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Zongguang Zhou, MD., PhD.

CONTACT

18980601007; zhou767@163.com

Yuan Yin, MD.

CONTACT

15680600588; yinyuan10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of gastrointestinal surgery center, WestChina Hospital

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

CN (4)