Spleen Preserving Surgery for Splenic Hydatidosis: A Coho... | NCT06289816

Studies
Spleen Preserving Surgery for Splenic Hydatidosis: A Cohort Study on Short and Long-Term Outcomes

NCT06289816

Sponsor

Yarmouk University

Status

Completed

Last Update Posted

Mar 4, 2024Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Spleen-Preserving Surgery
Echinococcus Granulosus Infection
Hydatid Disease
Minimally Invasive Surgery

Interventions

Minimally Invasive Surgery

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Feb 24, 2024

First Submission Date that Met QC Criteria

Feb 24, 2024

First Posted Date

Mar 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2024

Last Update Posted Date

Mar 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The study delves into a detailed analysis of 18 cases of primary splenic hydatid cysts treated through spleen-preserving surgeries-laparoscopic partial splenectomy, cystectomy, and cyst deroofing-augmented by albendazole therapy. It presents a comprehensive comparison based on patient demographics, symptoms, surgical details, and outcomes, including complications and recurrence rates. Findings reveal no significant statistical difference in recurrence rates between spleen-preserving methods and total splenectomy, suggesting the viability of less invasive approaches for managing this condition effectively while preserving spleen functionality and minimizing post-operative complications. The study underlines the need for individualized treatment plans and further research with larger cohorts.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimally Invasive Surgery	Procedure	Minimally Invasive Surgery : Laparoscopic partial splenectomy, cystectomy, and cyst deroofing.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anas Aljaiuossi		Irbid		22110	Jordan

Condition Browse Module

MeSH Terms

ID	Term
D004443	Echinococcosis
D012008	Recurrence

Ancestor Terms

ID	Term
D002590	Cestode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019060	Minimally Invasive Surgical Procedures

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided