NCT04763733

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2012

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

9.1 years

First QC Date

February 17, 2021

Last Update Submit

February 19, 2021

Conditions

Laparoscopic SplenectomyChildrenBenign Blood Diseases

Keywords

laparoscopic splenectomy,childrenprognostic scorebenign hematological diseases

Outcome Measures

Primary Outcomes (1)

  • prognosis of procedure

    number of patients with peritoneal collections, number of patients having pancreatitis, number of patients staying more than two days postoperative

    from day 0 to 7 days

Interventions

laparoscopic splenectomyOTHER

surgical

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with benign hematological diseases

You may not qualify if:

  • malignant hematological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of pediatric surgery
Post-Marketing Study
Yes

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

January 2, 2012

Primary Completion

February 14, 2021

Study Completion

February 16, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share