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

NCT05184647 | Unknown

• 1 other identifier: RECHMPL21_0712
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Splenectomy; Status

Keywords

Pediatrics; Non-malignant hemoglobinopathies; Comprative effectivness; Partial Splenectomy; Total Splenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of infectious event in total and partial splenectomy

  Day 1

• number of totalisation in partial

  Day 1

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Children between 0- 18 years olds
• Total or partial splenectomy
• Non malignant hémoglobinopathies

You may not qualify if:

• \- Total or partial splenectomy outside of non malignant hemoglobinopathies

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

Study Officials

• Nicolas KALFA

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Nicolas KALFA, MD

CONTACT

00334 67 33 87 84; n-kalfa@chu-montpellier.fr

Benoit Tessier, Student

CONTACT

4 67 33 87 84; benoitessier@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: January 16, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

FR (1)