Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

NCT04329845 | Completed

• 1 other identifier: zagazig 6
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Laparoscopic Surgery

Keywords

laparoscopy; laparotomy; non-penetrating; splenectomy

Outcome Measures

Primary Outcomes (1)

• mortality

  during operation or immediate postoperative

  1.5 years

Secondary Outcomes (1)

• intraoperative complications

  5 years

Study Arms (2)

open splenectomy for splenic injury in trauma

ACTIVE COMPARATOR

open splenectomy as a technique for removal of the spleen in case of injury to spleen

Procedure: open splenectomy

laparoscopic splenectomy for splenic injury in trauma

ACTIVE COMPARATOR

laparoscopic splenectomy as a technique for removal of the spleen in case of injury to spleen

Procedure: laparoscopic splenectomy for splenic injury in trauma

Interventions

open splenectomy PROCEDURE

open splenectomy for treatment of splenic injury

open splenectomy for splenic injury in trauma

laparoscopic splenectomy for splenic injury in trauma PROCEDURE

laparoscopy as a technique for removal of the spleen in injury

laparoscopic splenectomy for splenic injury in trauma

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• At least 15 years old.
• Male and female (not pregnant) patients; • Sonar and CT scans before surgery showed single splenic damage;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Officials

• tamer A. alnaimy, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: January 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2019
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share