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

December 22, 2021 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children under 18 years olds with partial or total splenectomy for non malignant hemoglobinopathies

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared the effectiveness with the number of transfusion
Time Frame: 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/
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of infectious event in total and partial splenectomy
Time Frame: Day 1
Number of infectious event in total and partial splenectomy
Day 1
number of totalisation in partial
Time Frame: Day 1
number of totalisation in partial
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 16, 2022

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 22, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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