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

Splenectomy; Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05184647
• Other study ID #: RECHMPL21_0712
• Status: Not yet recruiting
• Start date: January 16, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Nicolas KALFA, MD
• Phone: 00334 67 33 87 84
• Email: n-kalfa[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemoglobinopathies
• Splenectomy; Status

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared the effectiveness with the number of transfusion	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	Number of infectious event in total and partial splenectomy	Number of infectious event in total and partial splenectomy	Day 1
Secondary	number of totalisation in partial	number of totalisation in partial	Day 1