Hiatal Herniahiatal herniaNCT07138235
Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol
An observational study of Hiatal Hernia and Hiatal Hernia With Gastroesophageal Reflux Disease, run by Osh State University.
Trial summary
Nissen fundoplication with cruroraphy performed according to ERAS protocols in patients with HH complicated by GERD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hiatal Hernia, Hiatal Hernia With Gastroesophageal Reflux Disease
- What is being tested?
- laparoscopic hiatal hernia repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Aug 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 106 patients with grade III-IV HH complicated by GERD, who underwent laparoscopic cruroraphy and Nissen fundoplication using the ERAS protocol.
Inclusion Criteria: were clinically significant hiatal hernia complicated by GERD, confirmed endoscopically and by radiological methods, age from 18 to 80 years and ineffectiveness of drug therapy for more than 6 months.
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Exclusion Criteria: were patients who had previously undergone surgery on the upper abdominal organs and oncological diseases. All patients underwent a comprehensive preoperative examination, including general clinical and biochemical tests, ECG, endoscopy and X-ray of the esophagus, stomach and duodenum.
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About this study
Nissen fundoplication with cruroraphy performed according to ERAS protocols in patients with HH complicated by GERD.
Read the detailed description
The surgery was performed in accordance with the following stages. Preparation for surgery included premedication, thromboembolic prophylaxis, and intravenous administration of broad-spectrum antibiotics 30 minutes before induction of anesthesia. Patient position and approaches: the patient was on the operating table in the spinal position with the lower limbs abducted, the head was raised by 15-20° to improve visualization of the subdiaphragmatic space. Four ports were used: one 10-mm port in the umbilical region (for optics), two 5 mm ports in the right hypochondrium and epigastrium, and one 10 mm port in the left hypochondrium. Based on the analysis of early experience of laparoscopic interventions in the cardioesophageal zone, we modified the standard port technique. In particular, the rejection of the classic fan-shaped installation of five trocars turned out to be justified, since two trocars in the left hypochondrium anatomically conflict and limit the maneuverability of the instruments, also the use of an ultrasonic dissector, allowing for simultaneous coagulation and dissection of tissue, which significantly reduced the need for an additional assistant instrument. This ensured more ergonomic manipulations, reduced the duration of the operation and the need for an additional fifth port.
- Being tested
- laparoscopic hiatal hernia repair
- Keywords
- laparoscopic hiatal hernia repair,, ERAS protocol,, surgical outcomes
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hiatal hernia repairProcedure or surgery
Intraoperative endoscopic control and the use of calibration bougies allow for increasing the accuracy of cardiac sphincter reconstruction and reducing the risk of hyper- or hypocorrection. Endoscopic equipment. The Olympus EVIS EXERA III endoscopic video system (Olympus Medical Systems Corp., Tokyo, Japan), series 190, was used for diagnostic and therapeutic endoscopic examinations.
The complex included:
- CV-190 video processor with digital image magnification,
- CLV-190 light source (xenon/LED), providing high brightness and uniformity of illumination, a high definition (HD) video monitor,
- GIF-HQ190, GIF-H190 high-resolution series gastroscopes,
- CF-HQ190L/I series colonoscopes (if necessary). These functions made it possible to more accurately assess the condition of the mucous membrane of the esophagus and stomach, as well as to identify pathological changes.
Medications: omeprazole/esomeprazole, ondansetron, cephalosporins intravenously, metoclopramide.
What is being measured
The primary outcome is the main question the study is designed to answer.
decreased complication rate and high patient satisfaction
Measured: October 2016 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Oct 2016
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
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.
- 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
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osh State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kyrgyz State Medical Academy
- Responsible party
- Principal investigator, Zhypargul Abdullaeva, Osh State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138235
- Sponsor's protocol ID
- Laparoscopic hiatal hernia
- Acronym
- hiatal hernia
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol
- ClinicalTrials.gov ID
- NCT07138235
- Acronym / sponsor ID
- hiatal hernia / Laparoscopic hiatal hernia
- Keywords
- laparoscopic hiatal hernia repair,, ERAS protocol,, surgical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Osh State UniversityUniversity, hospital or other
- Collaborators
- Kyrgyz State Medical Academy
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 22 Aug 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.
Nissen fundoplication with cruroraphy performed according to ERAS protocols in patients with HH complicated by GERD.
Detailed description
The surgery was performed in accordance with the following stages. Preparation for surgery included premedication, thromboembolic prophylaxis, and intravenous administration of broad-spectrum antibiotics 30 minutes before induction of anesthesia. Patient position and approaches: the patient was on the operating table in the spinal position with the lower limbs abducted, the head was raised by 15-20° to improve visualization of the subdiaphragmatic space. Four ports were used: one 10-mm port in the umbilical region (for optics), two 5 mm ports in the right hypochondrium and epigastrium, and one 10 mm port in the left hypochondrium. Based on the analysis of early experience of laparoscopic interventions in the cardioesophageal zone, we modified the standard port technique. In particular, the rejection of the classic fan-shaped installation of five trocars turned out to be justified, since two trocars in the left hypochondrium anatomically conflict and limit the maneuverability of the instruments, also the use of an ultrasonic dissector, allowing for simultaneous coagulation and dissection of tissue, which significantly reduced the need for an additional assistant instrument. This ensured more ergonomic manipulations, reduced the duration of the operation and the need for an additional fifth port.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 106 patients with grade III-IV HH complicated by GERD, who underwent laparoscopic cruroraphy and Nissen fundoplication using the ERAS protocol.
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 |
|---|---|---|
| laparoscopic hiatal hernia repairIntraoperative endoscopic control and the use of calibration bougies allow for increasing the accuracy of cardiac sphincter reconstruction and reducing the risk of hyper- or hypocorrection. Endoscopic equipment. The Olympus EVIS EXERA III endoscopic video system (Olympus Medical Systems Corp., Tokyo, Japan), series 190, was used for diagnostic and therapeutic endoscopic examinations. The complex included: * CV-190 video processor with digital image magnification, * CLV-190 light source (xenon/LED), providing high brightness and uniformity of illumination, a high definition (HD) video monitor, * GIF-HQ190, GIF-H190 high-resolution series gastroscopes, * CF-HQ190L/I series colonoscopes (if necessary). These functions made it possible to more accurately assess the condition of the mucous membrane of the esophagus and stomach, as well as to identify pathological changes. Medications: omeprazole/esomeprazole, ondansetron, cephalosporins intravenously, metoclopramide. | Procedure or surgery | – |
Primary outcome
decreased complication rate and high patient satisfaction
Time frame: October 2016 to June 2025
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 22 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiatal Hernia and Hiatal Hernia With Gastroesophageal Reflux Disease, run by Osh State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Aug 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?
decreased complication rate and high patient satisfaction (time frame: October 2016 to June 2025). 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 22 Aug 2025.