Echinococcosis, HepaticSURGHIDANCT05420155
Surgical Treatment of Liver Hydatid Cyst (SURGHIDA)
An observational study of Echinococcosis, Hepatic, run by Universidad de Extremadura.
Trial summary
The aim was to analyses the incidence and the independent factors associated with Textbook Outcome following surgical treatment of liver hydatid cysts (LHC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echinococcosis, Hepatic
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 296 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 30 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, treated by total or partial pericystectomy
Who may be able to join
- Patients with liver hydatid cyst treated by total or partial pericystectomy
Who cannot join
- emergency surgery and simple drainage of cyst
About this study
Official title: Outcome After Surgical Treatment of Liver Hydatid Cyst
The aim was to analyses the incidence and the independent factors associated with Textbook Outcome following surgical treatment of liver hydatid cysts (LHC).
Read the detailed description
Textbook outcome (TO) is a composite measure to determine the ideal postoperative period and to assess the quality of surgical care. The aim was to analyses the incidence and the independent factors associated with TO following surgical treatment of liver hydatid cysts (LHC).
The investigators conducted a retrospective cohort study of patients operated on for hepatic hydatidosis between January 2006 to December 2021. TO occurred when all the following criteria were fulfilled: no mortality within 90 days, no major complications within 90 days, no reintervention within 90 days and no prolonged hospital stay. Univariable and multivariable analyses were performed to identify factors associated with TO.
- Conditions
- Echinococcosis, Hepatic
- Being tested
- Surgical resection
- Medical subject headings
- Echinococcosis, Hepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Surgical treatment of hepatic hydatidic cyst
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Patients operated on liver hydatidic cyst Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
no mortality within 90 days
Measured: 90 days
Morbidity
no major complications within 90 days
Measured: 90 days
Re-admission
no re-admissions within 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jan 2006
- Primary completion31 Dec 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Echinococcosis, HepaticStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Badajoz
- Responsible party
- Principal investigator, Gerardo Blanco-Fernández, Universidad de Extremadura
- Investigators
- Gerardo Blanco-Fernández, MD, PhD, Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420155
- Sponsor's protocol ID
- UE-CHUB-001-2022
- Acronym
- SURGHIDA
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manterola C, Otzen T, Urrutia S; MINCIR Group (Methodology and Research in Surgery). Risk factors of postoperative morbidity in patients with uncomplicated liver hydatid cyst. Int J Surg. 2014;12(7):695-9. doi: 10.1016/j.ijsu.2014.05.063. Epub 2014 May 21.
PubMed 24859488van Roessel S, Mackay TM, van Dieren S, van der Schelling GP, Nieuwenhuijs VB, Bosscha K, van der Harst E, van Dam RM, Liem MSL, Festen S, Stommel MWJ, Roos D, Wit F, Molenaar IQ, de Meijer VE, Kazemier G, de Hingh IHJT, van Santvoort HC, Bonsing BA, Busch OR, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Textbook Outcome: Nationwide Analysis of a Novel Quality Measure in Pancreatic Surgery. Ann Surg. 2020 Jan;271(1):155-162. doi: 10.1097/SLA.0000000000003451.
PubMed 31274651de la Plaza Llamas R, Ramia Angel JM, Bellon JM, Arteaga Peralta V, Garcia Amador C, Lopez Marcano AJ, Medina Velasco AA, Gonzalez Sierra B, Manuel Vazquez A. Clinical Validation of the Comprehensive Complication Index as a Measure of Postoperative Morbidity at a Surgical Department: A Prospective Study. Ann Surg. 2018 Nov;268(5):838-844. doi: 10.1097/SLA.0000000000002839.
PubMed 30303875Mehta R, Tsilimigras DI, Pawlik TM. Assessment of Magnet status and Textbook Outcomes among medicare beneficiaries undergoing hepato-pancreatic surgery for cancer. J Surg Oncol. 2021 Sep;124(3):334-342. doi: 10.1002/jso.26521. Epub 2021 May 7.
PubMed 33961716Jaen-Torrejimeno I, Lopez-Guerra D, Prada-Villaverde A, Blanco-Fernandez G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26.
PubMed 30809783
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Surgical Treatment of Liver Hydatid Cyst
- ClinicalTrials.gov ID
- NCT05420155
- Acronym / sponsor ID
- SURGHIDA / UE-CHUB-001-2022
- Conditions
- Echinococcosis, Hepatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Badajoz
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 15 Jun 2022 (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 aim was to analyses the incidence and the independent factors associated with Textbook Outcome following surgical treatment of liver hydatid cysts (LHC).
Detailed description
Textbook outcome (TO) is a composite measure to determine the ideal postoperative period and to assess the quality of surgical care. The aim was to analyses the incidence and the independent factors associated with TO following surgical treatment of liver hydatid cysts (LHC).
The investigators conducted a retrospective cohort study of patients operated on for hepatic hydatidosis between January 2006 to December 2021. TO occurred when all the following criteria were fulfilled: no mortality within 90 days, no major complications within 90 days, no reintervention within 90 days and no prolonged hospital stay. Univariable and multivariable analyses were performed to identify factors associated with TO.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: Surgical resectionPatients operated on liver hydatidic cyst |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, treated by total or partial pericystectomy
Key inclusion criteria (1 listed)
- Patients with liver hydatid cyst treated by total or partial pericystectomy
Key exclusion criteria (1 listed)
- emergency surgery and simple drainage of cyst
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 |
|---|---|---|
| Surgical resectionSurgical treatment of hepatic hydatidic cyst | Procedure or surgery | Surgical group |
Primary outcome
Mortality
Time frame: 90 days
no mortality within 90 days
Morbidity
Time frame: 90 days
no major complications within 90 days
Re-admission
Time frame: 90 days
no re-admissions within 90 days
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 15 Jun 2022.
- Background: PubMed 24859488Manterola C, Otzen T, Urrutia S; MINCIR Group (Methodology and Research in Surgery). Risk factors of postoperative morbidity in patients with uncomplicated liver hydatid cyst. Int J Surg. 2014;12(7):695-9. doi: 10.1016/j.ijsu.2014.05.063. Epub 2014 May 21.
- Background: PubMed 31274651van Roessel S, Mackay TM, van Dieren S, van der Schelling GP, Nieuwenhuijs VB, Bosscha K, van der Harst E, van Dam RM, Liem MSL, Festen S, Stommel MWJ, Roos D, Wit F, Molenaar IQ, de Meijer VE, Kazemier G, de Hingh IHJT, van Santvoort HC, Bonsing BA, Busch OR, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Textbook Outcome: Nationwide Analysis of a Novel Quality Measure in Pancreatic Surgery. Ann Surg. 2020 Jan;271(1):155-162. doi: 10.1097/SLA.0000000000003451.
- Background: PubMed 30303875de la Plaza Llamas R, Ramia Angel JM, Bellon JM, Arteaga Peralta V, Garcia Amador C, Lopez Marcano AJ, Medina Velasco AA, Gonzalez Sierra B, Manuel Vazquez A. Clinical Validation of the Comprehensive Complication Index as a Measure of Postoperative Morbidity at a Surgical Department: A Prospective Study. Ann Surg. 2018 Nov;268(5):838-844. doi: 10.1097/SLA.0000000000002839.
- Background: PubMed 33961716Mehta R, Tsilimigras DI, Pawlik TM. Assessment of Magnet status and Textbook Outcomes among medicare beneficiaries undergoing hepato-pancreatic surgery for cancer. J Surg Oncol. 2021 Sep;124(3):334-342. doi: 10.1002/jso.26521. Epub 2021 May 7.
- Background: PubMed 30809783Jaen-Torrejimeno I, Lopez-Guerra D, Prada-Villaverde A, Blanco-Fernandez G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26.
- Individual participant dataSharing planned: No
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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.
Gerardo Blanco-Fernández, MD, PhD study director
University of Extremadura
Questions about this trial
What is this clinical trial studying?
An observational study of Echinococcosis, Hepatic, run by Universidad de Extremadura.
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 1 inclusion and 1 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 15 Jun 2022. 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?
Mortality (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420155, which also lists 5 linked publications.
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 15 Jun 2022.