NCT01994148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

November 11, 2013

Last Update Submit

October 8, 2017

Conditions

Gastrointestinal Injury

Keywords

TraumaGastrointestinal injuryLaparoscopy

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

  • +1 more secondary outcomes

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

LaparoscopyPROCEDURE

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

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Zongguang Zhou, MD., PhD

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Zongguang Zhou, MD., PhD.

CONTACT

18980601007zhou767@163.com

Yuan Yin, MD.

CONTACT

15680600588yinyuan10@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)