Clincosm LogoSign in Get a demo

Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05184647
Collaborator
(none)
100
Enrollment
1
Location
11.4
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness
    Anticipated Study Start Date :
    Jan 16, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Children under 18 years olds with total splenectomy for non Malignant hemoglobinopathie

    Children under 18 years olds with total splenectomy for non Malignant hemoglobinopathie
    Children under 18 years olds with partial splenectomy for non Malignant hemoglobinopathie

    Children under 18 years olds with partial splenectomy for non Malignant hemoglobinopathie

    Outcome Measures

    Primary Outcome Measures

    1. Compared the effectiveness with the number of transfusion [Day 1]

      Compared the effectiveness with the number of transfusion after the surgery between total and partial Febrile urinary tract infection was defined as a positive urine examination with a single bacteria with more than 10.5 cfu/mL and more than 10.4 leukocytes/ml associated with fever above 38.5°C and C-reactive protein (CRP) above 50 mg/

    Secondary Outcome Measures

    1. Number of infectious event in total and partial splenectomy [Day 1]

      Number of infectious event in total and partial splenectomy

    2. number of totalisation in partial [Day 1]

      number of totalisation in partial

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Children between 0- 18 years olds

    • Total or partial splenectomy

    • Non malignant hémoglobinopathies

    Exclusion criteria:
    • Total or partial splenectomy outside of non malignant hemoglobinopathies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Nicolas KALFA, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05184647
    Other Study ID Numbers:
    • RECHMPL21_0712
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Pediatrics
    Non-malignant hemoglobinopathies
    Comprative effectivness
    Partial Splenectomy
    Total Splenectomy
    Additional relevant MeSH terms:
    Hemoglobinopathies

    Study Results

    No Results Posted as of Jan 11, 2022