Surgical Treatment of Hepatic Hydatidosis in Elderly Pati... | NCT05113550

Studies
Surgical Treatment of Hepatic Hydatidosis in Elderly Patients

NCT05113550

Sponsor

Universidad de Extremadura

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

279Actual

Phase

Not provided

Conditions

Cystic Echinococcosis

Interventions

Surgical remove

Countries

Spain

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

Oct 2021

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, 2021Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Oct 28, 2021

First Submission Date that Met QC Criteria

Oct 28, 2021

First Posted Date

Nov 9, 2021Actual

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

Nov 8, 2021

Last Update Posted Date

Nov 16, 2021Actual

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

Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.

Detailed Description

Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly.

Inclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy.

Exclusion criteria of patients: emergency surgery and simple drainage of cyst.

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

279Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Young group		patients < 70 years of age	Other: Surgical remove
Elderly		Patients ≥ 70 years of age)	Other: Surgical remove

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical remove	Other	liver hydatid cyst (LHC) treated by total or partial pericystectomy	Elderly Young group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morbidity	Patients with postoperative morbidity according to the Clavien-Dindo score 19, "severe complication" (Clavien-Dindo ≥ IIIa) and postoperative mortality	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver hydatid cyst (LHC)
pathological diagnosis after surgery
LHC treated by total or partial pericystectomy

Exclusion Criteria:

emergency surgery and simple drainage of cyst

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerardo Blanco-Fernández, MD, PhD	University of Extremadura	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Extremadura- Facultad de Medicina		Badajoz		06080	Spain
Gerardo Blanco-Fernández

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27729953	Background	Mihmanli M, Idiz UO, Kaya C, Demir U, Bostanci O, Omeroglu S, Bozkurt E. Current status of diagnosis and treatment of hepatic echinococcosis. World J Hepatol. 2016 Oct 8;8(28):1169-1181. doi: 10.4254/wjh.v8.i28.1169.
16400708	Background	Adamina M, Guller U, Weber WP, Oertli D. Propensity scores and the surgeon. Br J Surg. 2006 Apr;93(4):389-94. doi: 10.1002/bjs.5265.

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