Hiatal HerniaNCT07491003
Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty
A study testing Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG) in people with Hiatal Hernia and Sleeve Gastrectomy, run by Zagazig University at 1 site in Egypt.
Trial summary
The study you're referring to explores a surgical strategy for patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) who also have a Hiatal Hernia (HH). Because obesity is a major risk factor for hiatal hernias, surgeons often find these defects during bariatric procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia, Sleeve Gastrectomy
- What is being tested?
- Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jun 2025to 26 Feb 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adults (≥18 years), Patients underwent laparoscopic sleeve gastrectomy, Intraoperative confirmation of hiatal hernia, no prior history of esophageal or gastric surgery and Patient fit for general anesthesia
Who cannot join
- Patients with severe esophageal motility disorders, Patients with contraindications to laparoscopic surgery, Previous hiatal hernia repair, Esophageal stricture and perforation, Pregnancy or uncontrolled comorbidities, Presence of large paraesophageal hernias (>4 cm) with volvulus, Contraindications to laparoscopic surgery, such as severe cardiopulmonary disease and Contraindication for general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty Following Sleeve Gastrectomy: A Prospective Study
The study you're referring to explores a surgical strategy for patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) who also have a Hiatal Hernia (HH). Because obesity is a major risk factor for hiatal hernias, surgeons often find these defects during bariatric procedures
- Conditions
- Hiatal Hernia, Sleeve Gastrectomy
- Being tested
- Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)Procedure or surgery
The procedure was performed laparoscopically under general anesthesia with the patient in a 30° reverse Trendelenburg position. Following pneumoperitoneum and five-trocar insertion, any adhesions from the previous Sleeve Gastrectomy (LSG) were released to expose the hiatus.
Dissection: The gastrohepatic ligament was divided, and the hernia sac and gastroesophageal fat pad were fully reduced into the abdomen while preserving the hepatic branch of the vagus nerve.
Repair: The crural defect was closed using 2-3 interrupted non-absorbable sutures to achieve a tension-free repair.
Mesh Augmentation: A shaped polypropylene mesh was placed in an "onlay" fashion over the posterior crural repair, secured with endoscopic metal fixators, and covered with the remaining hernia sac flaps to protect the esophagus.
Closure: After confirming hemostasis, trocars were removed and ports closed. Postoperative Management: Patients followed a standardized protocol involving gradua
| Study group | Role | What they receive |
|---|---|---|
| hernia arm represent patients with hiatal hernia | Experimental | A single group of 20 adult patients undergoing intraoperative Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG) Receives: Procedure: Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Hiatal Hernia (HH) Recurrence Rate
The primary objective is to determine the incidence of hiatal hernia recurrence following Laparoscopic Sleeve Gastrectomy (LSG) with concurrent mesh cruroplasty
Measured: 6 months after the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start26 Jun 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasser Ali Orban, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491003
- Sponsor's protocol ID
- Laparoscopic hiatal hernia
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Hiatal Hernia Repair With Mesh Cruroplasty Following Sleeve Gastrectomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT07491003
- Acronym / sponsor ID
- Laparoscopic hiatal hernia
- Conditions
- Hiatal Hernia, Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 24 Mar 2026 (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 study you're referring to explores a surgical strategy for patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) who also have a Hiatal Hernia (HH). Because obesity is a major risk factor for hiatal hernias, surgeons often find these defects during bariatric procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hernia arm represent patients with hiatal hernia | Experimental | Procedure: Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)A single group of 20 adult patients undergoing intraoperative Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years), Patients underwent laparoscopic sleeve gastrectomy, Intraoperative confirmation of hiatal hernia, no prior history of esophageal or gastric surgery and Patient fit for general anesthesia
Key exclusion criteria (1 listed)
- Patients with severe esophageal motility disorders, Patients with contraindications to laparoscopic surgery, Previous hiatal hernia repair, Esophageal stricture and perforation, Pregnancy or uncontrolled comorbidities, Presence of large paraesophageal hernias (>4 cm) with volvulus, Contraindications to laparoscopic surgery, such as severe cardiopulmonary disease and Contraindication for general anesthesia.
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 |
|---|---|---|
| Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG)The procedure was performed laparoscopically under general anesthesia with the patient in a 30° reverse Trendelenburg position. Following pneumoperitoneum and five-trocar insertion, any adhesions from the previous Sleeve Gastrectomy (LSG) were released to expose the hiatus. Dissection: The gastrohepatic ligament was divided, and the hernia sac and gastroesophageal fat pad were fully reduced into the abdomen while preserving the hepatic branch of the vagus nerve. Repair: The crural defect was closed using 2-3 interrupted non-absorbable sutures to achieve a tension-free repair. Mesh Augmentation: A shaped polypropylene mesh was placed in an "onlay" fashion over the posterior crural repair, secured with endoscopic metal fixators, and covered with the remaining hernia sac flaps to protect the esophagus. Closure: After confirming hemostasis, trocars were removed and ports closed. Postoperative Management: Patients followed a standardized protocol involving gradua | Procedure or surgery | hernia arm represent patients with hiatal hernia |
Primary outcome
Evaluation of Hiatal Hernia (HH) Recurrence Rate
Time frame: 6 months after the surgical procedure.
The primary objective is to determine the incidence of hiatal hernia recurrence following Laparoscopic Sleeve Gastrectomy (LSG) with concurrent mesh cruroplasty
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 24 Mar 2026.
- 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.
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?
A study testing Hiatal Hernia (HH) repair using mesh cruroplasty during a Laparoscopic Sleeve Gastrectomy (LSG) in people with Hiatal Hernia and Sleeve Gastrectomy, run by Zagazig University at 1 site in Egypt.
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 24 Mar 2026. 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 Egypt. 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?
Evaluation of Hiatal Hernia (HH) Recurrence Rate (time frame: 6 months after the surgical procedure.). 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 24 Mar 2026.