Viewing Study NCT04763733


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Study NCT ID: NCT04763733
Status: COMPLETED
Last Update Posted: 2021-02-23
First Post: 2021-02-17
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Laparoscopic Splenectomy in Children
Sponsor: Tanta University
Organization:

Study Overview

Official Title: Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.
Status: COMPLETED
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: splenectomy
Brief Summary: Laparoscopic splenectomy (LS) gained popularity since it has been described for the first-time during nineties of past century. It has become "golden method" for splenectomy in all ages including children
Detailed Description: Background: laparoscopic splenectomy (LS) gained popularity during the last years in pediatric age group. Benign hematological diseases represent the main indications of that procedure. There are some score systems of difficulty of the technique but they are for adult patients. The aim is to develop a prognostic score system of LS in children with benign hematological diseases.

Methods: LS was performed in all children with benign hematological diseases. LS was done by the same team. They operated children in lateral decubitus position. The control of pedicle was achieved using bipolar sealing devices, polymer clips or endoscopic linear staplers. Preoperative, operative, and postoperative data were recorded and analyzed. Children were divided into two groups A and B according to the development of complications.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: True
Is a US Export?: None
Is an FDA AA801 Violation?: