ClinicalTrials.gg
CompletedNCT07138235hiatal herniaUpdated Aug 22, 2025

Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol

An observational study in Hiatal Hernia and Hiatal Hernia With Gastroesophageal Reflux Disease, sponsored by Osh State University. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Osh State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
106
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hiatal Hernia
  • Hiatal Hernia With Gastroesophageal Reflux Disease

Browse trials for

Keywords

  • laparoscopic hiatal hernia repair,
  • ERAS protocol,
  • surgical outcomes
03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's enrollment of 106 is below the median of 151 across 29 observational studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Osh State University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

106 patients with grade III-IV HH complicated by GERD, who underwent laparoscopic cruroraphy and Nissen fundoplication using the ERAS protocol.

Eligibility criteria

Inclusion Criteria: were 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.

-

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, , endoscopy and X-ray of the esophagus, stomach and duodenum.

-

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
106 participants (actual)
Patient registry
No

Interventions

  • Procedurelaparoscopic hiatal hernia repair

    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.

06

What researchers measure

Primary outcomes

  1. decreased complication rate and high patient satisfaction

    Time frame: October 2016 to June 2025

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07138235
Lead sponsor
Osh State University
Collaborators
Kyrgyz State Medical Academy
Responsible party
Zhypargul Abdullaeva (PhD, Lecturer, Osh State University) — Principal investigator
First posted
Aug 22, 2025
Start date
Oct 1, 2016
Primary completion
Aug 1, 2025
Completion
Aug 1, 2025
Last update
Aug 22, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion