Hiatus HerniaNCT06935617
Hiatus Hernia in Old
An observational study of Hiatus Hernia, run by Zagazig University.
Trial summary
hiatus hernia in frail patient is common and requires suregry Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hiatus Hernia
- What is being tested?
- nissein
- Type of treatment
- Surgery or procedure
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Mar 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly pt with hh
Who may be able to join
- EP aged ≥60 years for giant sliding HH with
Who cannot join
- • who required a concurrent abdominal procedure at the same time as fundoplication (e.g., cholecystectomy)(n=5)
- esophageal dysmotility(n=2)
- progressive systemic sclerosis (n=1)
About this study
Official title: Hiatus Hernia and Frailty
hiatus hernia in frail patient is common and requires suregry
Read the detailed description
severe frail patients had high incidence of recurrence
- Conditions
- Hiatus Hernia
- Being tested
- nissein
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nisseinProcedure or surgery
nissein surgery
| Study group | Role | What they receive |
|---|---|---|
| hiatus hernia | HH operated by LNF Receives: Procedure: nissein |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Mar 2016
- Primary completion1 Mar 2022
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatus HerniaStudies 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
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935617
- Sponsor's protocol ID
- Hiatus hernia
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hiatus Hernia and Frailty
- ClinicalTrials.gov ID
- NCT06935617
- Acronym / sponsor ID
- Hiatus hernia
- Conditions
- Hiatus Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 20 Apr 2025 (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.
hiatus hernia in frail patient is common and requires suregry
Detailed description
severe frail patients had high incidence of recurrence
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hiatus hernia | – | Procedure: nisseinHH operated by LNF |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly pt with hh
Key inclusion criteria (1 listed)
- EP aged ≥60 years for giant sliding HH with
Key exclusion criteria (3 listed)
- • who required a concurrent abdominal procedure at the same time as fundoplication (e.g., cholecystectomy)(n=5)
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 |
|---|---|---|
| nisseinnissein surgery | Procedure or surgery | hiatus hernia |
Primary outcome
recurrence
Time frame: three years
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 20 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Hiatus Hernia
Active, not recruiting
Gastropexy in the Repair of Patients With Paraesophageal Hernias
Paraesophageal Hernia
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
Active, not recruiting
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
GERD, Hiatal Hernia
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 Hiatus Hernia, run by Zagazig 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 1 inclusion and 3 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 20 Apr 2025. 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 (time frame: three 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 20 Apr 2025.