splenectomy: Laparoscopic Splenectomy in Children

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT04763733

Collaborator

(none)

137

Enrollment

109.5

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Splenectomy Children Benign Blood Diseases	Other: laparoscopic splenectomy	Phase 1

Detailed Description

Background: laparoscopic splenectomy (LS) gained popularity during the last years in pediatric age group. Benign hematological diseases represent the main indications of that procedure. There are some score systems of difficulty of the technique but they are for adult patients. The aim is to develop a prognostic score system of LS in children with benign hematological diseases.

Methods: LS was performed in all children with benign hematological diseases. LS was done by the same team. They operated children in lateral decubitus position. The control of pedicle was achieved using bipolar sealing devices, polymer clips or endoscopic linear staplers. Preoperative, operative, and postoperative data were recorded and analyzed. Children were divided into two groups A and B according to the development of complications.

Study Design

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.

Actual Study Start Date :

Jan 2, 2012

Actual Primary Completion Date :

Feb 14, 2021

Actual Study Completion Date :

Feb 16, 2021

Outcome Measures

Primary Outcome Measures

prognosis of procedure [from day 0 to 7 days]
number of patients with peritoneal collections, number of patients having pancreatitis, number of patients staying more than two days postoperative

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children with benign hematological diseases

Exclusion Criteria:

malignant hematological diseases

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Gharieb Mohammad Khirallah, assistant professor of pediatric surgery, Tanta University

ClinicalTrials.gov Identifier:

NCT04763733

Other Study ID Numbers:

33872/6/20

First Posted:

Feb 21, 2021

Last Update Posted:

Feb 23, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Mohammad Gharieb Mohammad Khirallah, assistant professor of pediatric surgery, Tanta University

laparoscopic splenectomy,

children

prognostic score

benign hematological diseases

Additional relevant MeSH terms:

Hematologic Diseases

Study Results

No Results Posted as of Feb 23, 2021