Spleen-Preserving SurgeryNCT06289816
Spleen Preserving Surgery for Splenic Hydatidosis: A Cohort Study on Short and Long-Term Outcomes
An observational study of Spleen-Preserving Surgery and Echinococcus Granulosus Infection, run by Yarmouk University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spleen-Preserving Surgery, Echinococcus Granulosus Infection, Hydatid Disease
- What is being tested?
- Minimally Invasive Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2015to 30 Jun 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Adult patients (age 14 years or older).
- Diagnosed exclusively with primary, non-recurrent splenic hydatid cysts.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Spleen Preserving Surgery to Treat Primary Splenic Hydatidosis: Short and Long Term Outcomes: A Cohort Study
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.
Read the 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.
- Conditions
- Spleen-Preserving Surgery, Echinococcus Granulosus Infection, Hydatid Disease, Minimally Invasive Surgery
- Being tested
- Minimally Invasive Surgery
- Keywords
- Spleen-Preserving Surgery, Primary Splenic Hydatid Cyst, Hydatid Disease, Minimally Invasive Surgery, Echinococcus granulosus, Recurrence
- Medical subject headings
- Echinococcosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive SurgeryProcedure or surgery
Minimally Invasive Surgery : Laparoscopic partial splenectomy, cystectomy, and cyst deroofing.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spleen-Preserving SurgeryStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yarmouk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Aljaiuossi, Yarmouk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289816
- Sponsor's protocol ID
- 28/01/2023
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Spleen Preserving Surgery to Treat Primary Splenic Hydatidosis: Short and Long Term Outcomes: A Cohort Study
- ClinicalTrials.gov ID
- NCT06289816
- Acronym / sponsor ID
- 28/01/2023
- Conditions
- Spleen-Preserving Surgery, Echinococcus Granulosus Infection, Hydatid Disease, Minimally Invasive Surgery
- Keywords
- Spleen-Preserving Surgery, Primary Splenic Hydatid Cyst, Hydatid Disease, Minimally Invasive Surgery, Echinococcus granulosus, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yarmouk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Mar 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Adult patients (age 14 years or older).
- Diagnosed exclusively with primary, non-recurrent splenic hydatid cysts.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Minimally Invasive SurgeryMinimally Invasive Surgery : Laparoscopic partial splenectomy, cystectomy, and cyst deroofing. | Procedure or surgery | – |
Primary outcome
Incidence of Postoperative Short-Term Complications
Time frame: Up to 1 month post-operation
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.
Incidence of Postoperative Long-Term Complications
Time frame: Up to 2 years post-operation
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.
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 Mar 2024.
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 Spleen-Preserving Surgery and Echinococcus Granulosus Infection, run by Yarmouk University at 1 site in Jordan.
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 Mar 2024. 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 Jordan. 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?
Incidence of Postoperative Short-Term Complications (time frame: Up to 1 month post-operation). The study lists 2 primary outcomes in all. 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 Mar 2024.