- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763733
Laparoscopic Splenectomy in Children (splenectomy)
Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children with benign hematological diseases
Exclusion Criteria:
- malignant hematological diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prognosis of procedure
Time Frame: from day 0 to 7 days
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33872/6/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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