NCT06289816

Brief Summary

This retrospective cohort study examines the effectiveness of minimally invasive spleen-preserving surgeries compared to total splenectomy for treating primary splenic hydatidosis in Jordan. Covering 18 patients from January 2015 to June 2021, the research highlights similar recurrence rates between both surgical approaches, emphasizing the benefits of spleen preservation in maintaining immune function and reducing septic risks, particularly in pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

6.5 years

First QC Date

February 24, 2024

Last Update Submit

February 24, 2024

Conditions

Keywords

Spleen-Preserving SurgeryPrimary Splenic Hydatid CystHydatid DiseaseMinimally Invasive SurgeryEchinococcus granulosusRecurrence

Outcome Measures

Primary Outcomes (2)

  • Incidence of Postoperative Short-Term Complications

    The measure focuses on the incidence and nature of short-term complications following spleen-preserving surgeries compared to total splenectomy. Short-term complications may include infection, bleeding, or any other immediate post-surgical issues that impact recovery.

    Up to 1 month post-operation

  • Incidence of Postoperative Long-Term Complications

    This measure assesses the long-term complications associated with spleen-preserving surgeries versus total splenectomy. Specifically, it examines the recurrence of hydatid cysts as a significant long-term complication.

    Up to 2 years post-operation

Interventions

Minimally Invasive Surgery : Laparoscopic partial splenectomy, cystectomy, and cyst deroofing.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study involved patients diagnosed with primary splenic hydatid cysts, from January 2015 to June 2021. The study included medical records of 18 patients aged 14 years or older, diagnosed exclusively with primary, non-recurrent splenic hydatid cysts. Exclusion criteria encompassed individuals under 14 years, patients in late pregnancy, those with recurrent cysts, extra-splenic involvement, or less than two years of postoperative follow-up.

You may qualify if:

  • Adult patients (age 14 years or older).
  • Diagnosed exclusively with primary, non-recurrent splenic hydatid cysts.

You may not qualify if:

  • Children under 14 years of age.
  • Patients in late pregnancy.
  • Individuals with recurrent cysts.
  • Cases with extra-splenic involvement.
  • Patients with less than two years of postoperative follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anas Aljaiuossi

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

EchinococcosisRecurrence

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Cestode InfectionsHelminthiasisParasitic DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Hepatobiliary Surgeon

Study Record Dates

First Submitted

February 24, 2024

First Posted

March 4, 2024

Study Start

January 1, 2015

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations