Back to resultsLaparoscopic Splenectomy in Children (splenectomy)
Primary Purpose
Laparoscopic Splenectomy, Children, Benign Blood Diseases
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
laparoscopic splenectomy
Sponsored by
About this trial
This is an interventional health services research trial for Laparoscopic Splenectomy focused on measuring laparoscopic splenectomy,, children, prognostic score, benign hematological diseases
Eligibility Criteria
Inclusion Criteria:
- children with benign hematological diseases
Exclusion Criteria:
- malignant hematological diseases
Sites / Locations
Outcomes
Primary Outcome Measures
prognosis of procedure
number of patients with peritoneal collections, number of patients having pancreatitis, number of patients staying more than two days postoperative
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04763733
Brief Title
Laparoscopic Splenectomy in Children
Acronym
splenectomy
Official Title
Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2012 (Actual)
Primary Completion Date
February 14, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Pediatric Postmarket Surveillance of a Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Splenectomy, Children, Benign Blood Diseases
Keywords
laparoscopic splenectomy,, children, prognostic score, benign hematological diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
laparoscopic splenectomy
Intervention Description
surgical
Primary Outcome Measure Information:
Title
prognosis of procedure
Description
number of patients with peritoneal collections, number of patients having pancreatitis, number of patients staying more than two days postoperative
Time Frame
from day 0 to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with benign hematological diseases
Exclusion Criteria:
malignant hematological diseases
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Splenectomy in Children
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