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OpenTrials
Completed

NCT Number: NCT04329845

Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

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.

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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

open splenectomy

Procedure

open splenectomy for treatment of splenic injury

laparoscopic splenectomy for splenic injury in trauma

Procedure

laparoscopy as a technique for removal of the spleen in injury

Primary outcomes

  1. mortality

    Time frame: 1.5 years

    during operation or immediate postoperative

Secondary outcomes

  1. intraoperative complications

    Time frame: 5 years

    intraoperative complications

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Apr 1, 2020
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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