Hydatid CystNCT04988958
Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts
An observational study of Hydatid Cyst, run by Université de Sousse.
Trial summary
The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Hydatid Cyst
- What is being tested?
- hydatid cyst resection
- Type of treatment
- Surgery or procedure
- How many people
- 914 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 914 Patients , who underwent surgical treatment at the Department of General and Digestive Surgery, Sahloul University Hospital Center, Sousse, Tunisia from 1st January 2000 to 31st December 2019 was performed. The diagnosis of LHC was established by clinical history, physical examination and abdominal ultrasonography (USG) in all patients
Who may be able to join
- age over 14 years old.
- Patients presenting liver hydatid cyst .
Who cannot join
- age less than 14 years old.
- Patients presenting other localization of hydtic cyst , than the liver.
- calcified cysts.
- patients with incomplete medical records.
- patients who were lost to follow up.
About this study
Official title: Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts: A Propensity Score Matching Analysis
The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).
Read the detailed description
The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).
Data from all patients with LHC treated in Sahloul Hospital, between January 2000 and December 2019, were retrieved from a retrospective database. To minimize selection bias, propensity score matching (PSM) was performed, based on variables representing patient characteristics and operative risk factors.
RS especially total pericystectomy had fewer postoperative complications and lower recurrence rate compared to CS. RS may be the preferred procedure for LHC if the expertise is available.
- Conditions
- Hydatid Cyst
- Being tested
- hydatid cyst resection
- Medical subject headings
- Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydatid cyst resectionProcedure or surgery
radical resection of hydatic cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of hydatic cyst
recurrence of hydatid cyst after surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Jan 2000
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatid CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ammar houssem, Université de Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988958
- Sponsor's protocol ID
- U23477
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts: A Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT04988958
- Acronym / sponsor ID
- U23477
- Conditions
- Hydatid Cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).
Detailed description
The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).
Data from all patients with LHC treated in Sahloul Hospital, between January 2000 and December 2019, were retrieved from a retrospective database. To minimize selection bias, propensity score matching (PSM) was performed, based on variables representing patient characteristics and operative risk factors.
RS especially total pericystectomy had fewer postoperative complications and lower recurrence rate compared to CS. RS may be the preferred procedure for LHC if the expertise is available.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 914 Patients , who underwent surgical treatment at the Department of General and Digestive Surgery, Sahloul University Hospital Center, Sousse, Tunisia from 1st January 2000 to 31st December 2019 was performed. The diagnosis of LHC was established by clinical history, physical examination and abdominal ultrasonography (USG) in all patients
Key inclusion criteria (2 listed)
- age over 14 years old.
- Patients presenting liver hydatid cyst .
Key exclusion criteria (5 listed)
- age less than 14 years old.
- Patients presenting other localization of hydtic cyst , than the liver.
- calcified cysts.
- patients with incomplete medical records.
- patients who were lost to follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydatid cyst resectionradical resection of hydatic cyst | Procedure or surgery | – |
Primary outcome
recurrence of hydatic cyst
Time frame: 2 years
recurrence of hydatid cyst after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydatid Cyst, run by Université de Sousse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of hydatic cyst (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.