Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

Laparoscopic Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329845
• Other study ID #: zagazig 6
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 1, 2019
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Procedure:
• open splenectomy
open splenectomy for treatment of splenic injury
• laparoscopic splenectomy for splenic injury in trauma
laparoscopy as a technique for removal of the spleen in injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	during operation or immediate postoperative	1.5 years
Secondary	intraoperative complications	intraoperative complications	5 years