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Laparoscopic Splenectomy in Children (splenectomy)

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ClinicalTrials.gov Identifier: NCT04763733
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Mohammad Gharieb Mohammad Khirallah, Tanta University

Study Description
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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

Condition or disease Intervention/treatment Phase
Laparoscopic Splenectomy Children Benign Blood Diseases Other: laparoscopic splenectomy Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.
Actual Study Start Date : January 2, 2012
Actual Primary Completion Date : February 14, 2021
Actual Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Arms and Interventions
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Intervention Details:
  • Other: laparoscopic splenectomy
    surgical

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with benign hematological diseases

Exclusion Criteria:

  • malignant hematological diseases
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Mohammad Gharieb Mohammad Khirallah, assistant professor of pediatric surgery, Tanta University
ClinicalTrials.gov Identifier: NCT04763733    
Other Study ID Numbers: 33872/6/20
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Mohammad Gharieb Mohammad Khirallah, Tanta University:
laparoscopic splenectomy,
children
prognostic score
benign hematological diseases
Additional relevant MeSH terms:
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Hematologic Diseases