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NCT04763733 Clinical Trial

Laparoscopic Splenectomy in Children

Children Clinical Trial

— splenectomy  

Official title:
Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04763733
Other study ID # 33872/6/20
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2, 2012
Est. completion date February 16, 2021

Study information
Verified date February 2021
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date February 16, 2021
Est. primary completion date February 14, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria: - children with benign hematological diseases Exclusion Criteria: - malignant hematological diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• laparoscopic splenectomy
surgical

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Outcome
Type Measure Description Time frame Safety issue
Primary prognosis of procedure number of patients with peritoneal collections, number of patients having pancreatitis, number of patients staying more than two days postoperative from day 0 to 7 days
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