Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04329845
Collaborator
(none)
2
2
84

Study Details

Study Description

Brief Summary

Background: No criteria define indications for laparoscopic splenectomy in trauma. This investigation compared characteristics of trauma patients and outcomes between laparoscopic and open splenectomie Methods: Included patients were 15 or older, with a blunt splenic injury from January, 2012 to July 2017, and required splenectomy. Variables included demographics, splenic injury grade, approach (open or laparoscopic), duration of operation, intra-operative blood loss, transfusions, length of hospital stay, complications and mortality..

Condition or Disease Intervention/Treatment Phase
  • Procedure: open splenectomy
  • Procedure: laparoscopic splenectomy for splenic injury in trauma
N/A

Detailed Description

  1. INTRODUCTION

The spleen is liable to injury in trauma to the left lower chest or left upper abdomen. Other possible injuries that may be occur together with splenic injuries are injuries to the rib cage, diaphragm, pancreas, and bowel. Hemodynamic instability, a rising pulse rate and low blood pressure, are reliable signs of an injury but a high index of suspicion based on the mechanism of injury is needed.

Over the past 2 decades, in the developed world, computed tomography scanning has become the gold standard for imaging in hemodynamically stable patients with blunt abdominal trauma especially now that computed tomography scanners are in close vicinity to resuscitation areas in accident and emergency departments.

Laparoscopic total splenectomies in trauma patients were initially described as case reports in 1995 .

The Society of American Gastrointestinal and Endoscopic Surgeons'guidelines on laparoscopy for trauma stated that diagnostic laparoscopy is accept for patients who are haemodynamically stable,and without evidence of another injury requiring laparotomy.

Patients requiring surgery for splenic injury are hemodynamically unstable and/or actively bleeding, which prohibits the use of laparoscopy because of time and visualization constraints Advantages of laparoscopic approach are • Less postoperative pain ,Shorter hospital stay Faster return to a regular, solid food diet Quicker return to normal activities Better cosmetic results Laparoscopic exploration of the abdominal cavity excluded any bleeding injuries of the liver or other viscera, confirmed the splenic rupture, and permitted grading of the lesions for planning of the appropriate treatment.The incidence of missed injury in laparoscopy for trauma is extremely variable, ranging from 41% to 77%. Part of this wide variation may be explained by the fact that trauma surgeons typically perform fewer laparoscopic procedures Discussion

A study in 2015, comparing 23 laparoscopic splenectomies and 19 open splenectomies for grade III lacerations. The results showed longer operating times in the laparoscopic group, but no difference in complications or mortality, which is similar to the current investigation. A study with a smaller sample reviewed 11 hemodynamically stable, emergent laparoscopic splenectomies in grade III injuries The results demonstrated low morbidity and no deaths, suggesting that, in this population, laparoscopic splenectomy may be a safe alternative compared with open laparotomy.

There is evolving in the role of laparoscopy in splenic trauma management in the last years. Some of those changes have been related to new technology (harmonic scalpel). A study offered the advantage of using harmonic scalpel as effective hemostatic cutting where Dissection of injured viscera and attachments is often hindered by infiltration by hematomas.

Laparoscopic splenectomy offers many well-documented advantages over open procedures like decreased postoperative pain, decreased postoperative ICU admission time, and earlier return to normal daily activity.

inspection of the abdominal cavity and solid viscera is relatively easy to perform, complete examination of the intestine presents a greater challenge, with a 9% to 18% missed injury rate per patient

The spleen is delivered by use of commercially puncture resistant bag. The bag is delivered out through one of the port and the spleen is morcellated before removal. The cost of the bag prevented us from its routine use. When this endobag is not available,spleen is removed through 5-8 cm pfannesteinl incision.in our study, the spleen is removed in endobag in all cases.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. mortality [1.5 years]

    during operation or immediate postoperative

Secondary Outcome Measures

  1. intraoperative complications [5 years]

    intraoperative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • Age: 15 years and more.

  • Sex: male and non-pregnant female.

  • Preoperative sonar and CT evidence of isolated splenic injuries,

  • Blood pressure

Exclusion Criteria:
  • • Associated other abdominal or thoracic or neurological injuries detected preoperatively.

  • successful nonoperative management, or successful embolization

  • Pregnant female.

  • Penetrating splenic injuries.

  • Previous upper abdominal surgery for laparoscopic approach.

  • Other abdominal injuries detected during surgery (liver,intestine and urinary bladder injuries).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zagazig University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tamer Alsaied Alnaimy, assistant professour, Zagazig University
ClinicalTrials.gov Identifier:
NCT04329845
Other Study ID Numbers:
  • zagazig 6
First Posted:
Apr 1, 2020
Last Update Posted:
Jan 11, 2021
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tamer Alsaied Alnaimy, assistant professour, Zagazig University

Study Results

No Results Posted as of Jan 11, 2021