Spleen; Cyst, Hydatid (Manifestation)NCT04890899
Splenic Surgery for Hydatid Spleen in Single Institutional Experience
An observational study of Spleen; Cyst, Hydatid (Manifestation), run by Jabir Ibn Hayyan Medical University.
Trial summary
Splenic-preserving surgery in hydatid spleen: Single intuitional experience Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spleen; Cyst, Hydatid (Manifestation)
- What is being tested?
- Cystic enculation of spleen hydatid
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2013to 25 Jan 2020
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: from 5- 40 years (mean 23.6 years).
Who may be able to join
- Single hydatid spleen Primary spleen hydatid
- -
Who cannot join
- Multiple splenic hydatid Rupture hydatid spleen
About this study
Official title: Splenic Preserving Surgery in Hydatid Spleen
Splenic-preserving surgery in hydatid spleen: Single intuitional experience
Read the detailed description
Background:
Although hydatid disease affects many organs in the human body, splenic hydatid represents about 0.8-4% of all human echinococcosis cases. Until recently, splenectomy was the recommended surgical procedure for splenic hydatid. Since 1980 there has been an increasing tendency to use conservative option to deal with such pathology.
Aim of the study:
To evaluate our experience in open splenic-preserving surgery for splenic hydatid in a single institutional study.
Patient and methods:
A retrospective study. Ten patients with splenic hydatid were operated upon from August 2013 to January 2018 in our medical centre. Spleen has affected alone in 7 cases, liver and spleen were affected in 3 cases, and one of them had intraperitoneal cyst affection in addition. The diagnosis confirmed mainly by ultrasonography. In some cases, it computed tomography CT scan, and magnetic resonance imaging MRI were needed. Chest X-ray had taken for all patients to exclude pulmonary hydatid. The open surgical procedure used. Isolation of the field, aspiration of cystic fluid and injection of 1% cetrimide solution, re-aspiration, endocystectomy, suturing of cystic edges over intracystic tube drain. All surgery did under cover of albendazole pre and postoperative 15mg/kg/day.
Results:
No significant intraoperative and postoperative complications. No reoperation was needed. Hospital stays 3-5 days. No recurrence after (1-3) year follow-up. However, three patients missed follow-up after two years.
Conclusion:
Our experience in splenic hydatid encourages us to use splenic-preserving surgery whenever possible instead of splenectomy.
- Conditions
- Spleen; Cyst, Hydatid (Manifestation)
- Being tested
- Cystic enculation of spleen hydatid
- Keywords
- Spleen, Hydatid cyst, Surgery, Preserving surgery
- Medical subject headings
- Cysts, Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystic enculation of spleen hydatidProcedure or surgery
Preoperative preparation did according to the general condition of the patient and fitness for anaesthesia. Laparotomy did under general anaesthesia, supine position, the abdomen opened either by midline or left subcostal incision. Identification of splenic hydatid cyst. Exploration of the peritoneal cavity for undetected hepatic or peritoneal hydatid preoperatively. Isolation of operative field by packs socked with hypertonic solution (20 -30 % hypertonic saline). Aspiration of the cyst fluid. Injection of suitable amount about 5 ml of (1 % of cetramid) solution and waiting for at least 5 minutes and then re-aspiration. The spleen is not needed to mobilize. Extraction of the endocyst and washing of the cavity with normal saline. Occupying the cystic cavity intracystic drain. Perioperative and postoperative close observation of the patient for an anaphylactic reaction or any other complication. Follow-up of the patient until discharge from hospital on (3th - 5th) days.
What is being measured
The primary outcome is the main question the study is designed to answer.
splenic sparing surgery for hydatid spleen
Six of them males and four females, their age range from 5- 40 years (mean 23.6 years). Hydatid spleen alone was found in seven cases while splenic and liver hydatid was found in three cases one of them had peritoneal hydatid affection in addition. Hospital stay was ranged from 3-5 days.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start20 Aug 2013
- Primary completion19 Jan 2018
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spleen; Cyst, Hydatid (Manifestation)Studies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jabir Ibn Hayyan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890899
- Sponsor's protocol ID
- JabirIbnHayyanMU
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Splenic surgery for hydatid spleen, preserve the spleen
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splenic Preserving Surgery in Hydatid Spleen
- ClinicalTrials.gov ID
- NCT04890899
- Acronym / sponsor ID
- JabirIbnHayyanMU
- Conditions
- Spleen; Cyst, Hydatid (Manifestation)
- Keywords
- Spleen, Hydatid cyst, Surgery, Preserving surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jabir Ibn Hayyan Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2013 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 18 May 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.
Splenic-preserving surgery in hydatid spleen: Single intuitional experience
Detailed description
Background:
Although hydatid disease affects many organs in the human body, splenic hydatid represents about 0.8-4% of all human echinococcosis cases. Until recently, splenectomy was the recommended surgical procedure for splenic hydatid. Since 1980 there has been an increasing tendency to use conservative option to deal with such pathology.
Aim of the study:
To evaluate our experience in open splenic-preserving surgery for splenic hydatid in a single institutional study.
Patient and methods:
A retrospective study. Ten patients with splenic hydatid were operated upon from August 2013 to January 2018 in our medical centre. Spleen has affected alone in 7 cases, liver and spleen were affected in 3 cases, and one of them had intraperitoneal cyst affection in addition. The diagnosis confirmed mainly by ultrasonography. In some cases, it computed tomography CT scan, and magnetic resonance imaging MRI were needed. Chest X-ray had taken for all patients to exclude pulmonary hydatid. The open surgical procedure used. Isolation of the field, aspiration of cystic fluid and injection of 1% cetrimide solution, re-aspiration, endocystectomy, suturing of cystic edges over intracystic tube drain. All surgery did under cover of albendazole pre and postoperative 15mg/kg/day.
Results:
No significant intraoperative and postoperative complications. No reoperation was needed. Hospital stays 3-5 days. No recurrence after (1-3) year follow-up. However, three patients missed follow-up after two years.
Conclusion:
Our experience in splenic hydatid encourages us to use splenic-preserving surgery whenever possible instead of splenectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- from 5- 40 years (mean 23.6 years).
Key inclusion criteria (2 listed)
- Single hydatid spleen Primary spleen hydatid
- -
Key exclusion criteria (1 listed)
- Multiple splenic hydatid Rupture hydatid spleen
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 |
|---|---|---|
| Cystic enculation of spleen hydatidPreoperative preparation did according to the general condition of the patient and fitness for anaesthesia. Laparotomy did under general anaesthesia, supine position, the abdomen opened either by midline or left subcostal incision. Identification of splenic hydatid cyst. Exploration of the peritoneal cavity for undetected hepatic or peritoneal hydatid preoperatively. Isolation of operative field by packs socked with hypertonic solution (20 -30 % hypertonic saline). Aspiration of the cyst fluid. Injection of suitable amount about 5 ml of (1 % of cetramid) solution and waiting for at least 5 minutes and then re-aspiration. The spleen is not needed to mobilize. Extraction of the endocyst and washing of the cavity with normal saline. Occupying the cystic cavity intracystic drain. Perioperative and postoperative close observation of the patient for an anaphylactic reaction or any other complication. Follow-up of the patient until discharge from hospital on (3th - 5th) days. | Procedure or surgery | – |
Primary outcome
splenic sparing surgery for hydatid spleen
Time frame: 3 year
Six of them males and four females, their age range from 5- 40 years (mean 23.6 years). Hydatid spleen alone was found in seven cases while splenic and liver hydatid was found in three cases one of them had peritoneal hydatid affection in addition. Hospital stay was ranged from 3-5 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 18 May 2021.
- Individual participant dataSharing planned: Yes. Splenic surgery for hydatid spleen, preserve the spleen
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 Spleen; Cyst, Hydatid (Manifestation), run by Jabir Ibn Hayyan Medical University.
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 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 18 May 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?
splenic sparing surgery for hydatid spleen (time frame: 3 year). 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 18 May 2021.