Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

March 26, 2024 updated by: Tamer.A.A.M.Habeeb, Zagazig University

Myth and Facts About the Evolving Role of Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries in Hemodynamically Stable Patients With Blunt Abdominal Trauma .Randomized Controlled Trials

Background: Trauma laparoscopic splenectomy has no defined reasons. Compared trauma patient characteristics and results with laparoscopic and open splenectomies.

Methods: Patients aged 15 or older with blunt splenic injuries from January 2012 to July 2017 needed splenectomy. Demographics, splenic damage grade, approach (open or laparoscopic), surgery duration, intra-operative blood loss, transfusions, hospital stay, complications, and death were variables.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The spleen might be injured in left lower chest or upper abdomen trauma. Rib cage, diaphragm, pancreas, and bowel injuries may occur with splenic injuries. Hemodynamic instability, a rising heart rate, and low blood pressure are symptoms of damage, however the mechanism of injury requires a high index of suspicion.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • At least 15 years old.

    • Male and female (not pregnant) patients; • Sonar and CT scans before surgery showed single splenic damage;

Exclusion Criteria:

  • • Other damage to the abdomen, thorax, or nerves were found before surgery.

    • good use of non-surgical treatment or embolization
    • Woman who is pregnant.
    • Splenic cuts that go deep.
    • Previous surgery in the upper abdomen using a laparoscopic method. • Other injuries to the abdomen found during surgery, such as liver, intestine, or bladder injuries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open splenectomy for splenic injury in trauma
open splenectomy as a technique for removal of the spleen in case of injury to spleen
Procedure: open splenectomy
open splenectomy for treatment of splenic injury
Active Comparator: laparoscopic splenectomy for splenic injury in trauma
laparoscopic splenectomy as a technique for removal of the spleen in case of injury to spleen
Procedure: laparoscopic splenectomy for splenic injury in trauma
laparoscopy as a technique for removal of the spleen in injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 1.5 years
during operation or immediate postoperative
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative complications
Time Frame: 5 years
intraoperative complications
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: tamer A. alnaimy, MD, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • zagazig 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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