Patients Who Underwent Surgury for Hydatid CystNCT04363151
The Current Study Aimed to Evaluate the Therapeutic Features and Complications of Liver Hydatid Cyst in Patients Who Underwent Surgery for CE in Fars Province, Southern Iran.
An observational study of Patients Who Underwent Surgury for Hydatid Cyst, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The current study aimed to evaluate the therapeutic features and complications of liver hydatid cyst in patients who underwent surgery for CE in Fars province, southern Iran. A total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in Fars Province, southern Iran, were retrospectively… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Who Underwent Surgury for Hydatid Cyst
- How many people
- 293 participants
- Where
- 1 siteIran
- Study dates
- 15 Jan 2004to 25 Dec 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran.
Who may be able to join
- Having a surgery due to Hydatid cyst
Who cannot join
- Surgeries other than hydatid cyst.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Liver Hydatid Cysts: A Retrospective Analysis of 293 Cases From Southern Iran
The current study aimed to evaluate the therapeutic features and complications of liver hydatid cyst in patients who underwent surgery for CE in Fars province, southern Iran.
A total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in Fars Province, southern Iran, were retrospectively evaluated. The clinical records of patients were reviewed and the demographic and clinical characteristics of each patient were assessed.
Read the detailed description
Fars province with the capital of Shiraz in one of the thirty-one provinces of Iran located in the southwest part of the country with a population of more than 4.6 million people of which 67.6% living in urban areas, 32.2% in rural areas and 0.3% live as nomad tribes. The average temperature of Fars province is 17.8 °C, ranging between 4.7 °C and 29.2 °C and the annual rainfall is 261mm. Animal farming and agriculture are of great importance as they are considered as two main economic bases of this province. This type of livelihood has facilitated the presence of some of the zoonotic diseases such as CE and toxocariasis and leishmaniasis.
Data Collection Hospital records of a total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran, were retrospectively evaluated. In all cases, the preliminary diagnosis of hydatid cyst has been confirmed by postoperative pathological findings. So, the inclusion criterion of operation with the diagnosis of CE was considered while reviewing the records.
Information such as age, sex, presenting signs and symptoms of hydatid cyst, number and the specific location of cystic structures, history of relapse, reoperation, characteristics of the cyst (calcification, puss discharge, multicystic, multiloculated, daughter cyst, rupture, inflammation, superimposed infection, and septation), early postoperative complications, diagnostic procedures such as ultrasound scanning, computed tomography, X-rays, pathology reports, lab data, operation information and, drug therapy were extracted from the hospital records of each patient. The surgical procedure used for the patients, radical or conservative, was noted.
- Being tested
- No intervention.
- Keywords
- Hydatid cyst, Surgery, hospital record
- Medical subject headings
- Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
| Study group | Role | What they receive |
|---|---|---|
| Hydatid cyst patients | patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information as well as patients clinical data were extracted from the hospital records of each patient.
Measured: 2004 to 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start15 Jan 2004
- Primary completion25 Dec 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Underwent Surgury 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahador Sarkari, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363151
- Sponsor's protocol ID
- 94-01-01-9212
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individuals' data will not be shared with other researchers, as there is no need to do so.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Liver Hydatid Cysts: A Retrospective Analysis of 293 Cases From Southern Iran
- ClinicalTrials.gov ID
- NCT04363151
- Acronym / sponsor ID
- 94-01-01-9212
- Keywords
- Hydatid cyst, Surgery, hospital record
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2004 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 27 Apr 2020 (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 current study aimed to evaluate the therapeutic features and complications of liver hydatid cyst in patients who underwent surgery for CE in Fars province, southern Iran.
A total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in Fars Province, southern Iran, were retrospectively evaluated. The clinical records of patients were reviewed and the demographic and clinical characteristics of each patient were assessed.
Detailed description
Fars province with the capital of Shiraz in one of the thirty-one provinces of Iran located in the southwest part of the country with a population of more than 4.6 million people of which 67.6% living in urban areas, 32.2% in rural areas and 0.3% live as nomad tribes. The average temperature of Fars province is 17.8 °C, ranging between 4.7 °C and 29.2 °C and the annual rainfall is 261mm. Animal farming and agriculture are of great importance as they are considered as two main economic bases of this province. This type of livelihood has facilitated the presence of some of the zoonotic diseases such as CE and toxocariasis and leishmaniasis.
Data Collection Hospital records of a total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran, were retrospectively evaluated. In all cases, the preliminary diagnosis of hydatid cyst has been confirmed by postoperative pathological findings. So, the inclusion criterion of operation with the diagnosis of CE was considered while reviewing the records.
Information such as age, sex, presenting signs and symptoms of hydatid cyst, number and the specific location of cystic structures, history of relapse, reoperation, characteristics of the cyst (calcification, puss discharge, multicystic, multiloculated, daughter cyst, rupture, inflammation, superimposed infection, and septation), early postoperative complications, diagnostic procedures such as ultrasound scanning, computed tomography, X-rays, pathology reports, lab data, operation information and, drug therapy were extracted from the hospital records of each patient. The surgical procedure used for the patients, radical or conservative, was noted.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydatid cyst patients | – | Other: No intervention.patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran.
Key inclusion criteria (1 listed)
- Having a surgery due to Hydatid cyst
Key exclusion criteria (2 listed)
- Surgeries other than hydatid 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 |
|---|---|---|
| No intervention. | Other | Hydatid cyst patients |
Primary outcome
Demographic Information as well as patients clinical data were extracted from the hospital records of each patient.
Time frame: 2004 to 2018
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 28 Apr 2020.
- Individual participant dataSharing planned: No. The individuals' data will not be shared with other researchers, as there is no need to do so.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Who Underwent Surgury for Hydatid Cyst, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 2 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Demographic Information as well as patients clinical data were extracted from the hospital records of each patient. (time frame: 2004 to 2018). 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 28 Apr 2020.