Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

NCT ID: NCT04329845

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2019-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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open splenectomy for splenic injury in trauma

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

Group Type ACTIVE_COMPARATOR

open splenectomy

Intervention Type PROCEDURE

open splenectomy for treatment of splenic injury

laparoscopic splenectomy for splenic injury in trauma

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

Group Type ACTIVE_COMPARATOR

laparoscopic splenectomy for splenic injury in trauma

Intervention Type PROCEDURE

laparoscopy as a technique for removal of the spleen in injury

Interventions

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open splenectomy

open splenectomy for treatment of splenic injury

Intervention Type PROCEDURE

laparoscopic splenectomy for splenic injury in trauma

laparoscopy as a technique for removal of the spleen in injury

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tamer.A.A.M.Habeeb

assistant professour

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tamer A. alnaimy, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Other Identifiers

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zagazig 6

Identifier Type: -

Identifier Source: org_study_id

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