NCT07138235

Brief Summary

Nissen fundoplication with cruroraphy performed according to ERAS protocols in patients with HH complicated by GERD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

8.8 years

First QC Date

August 11, 2025

Last Update Submit

August 17, 2025

Conditions

Hiatal HerniaHiatal Hernia With Gastroesophageal Reflux Disease

Keywords

laparoscopic hiatal hernia repair,ERAS protocol,surgical outcomes

Outcome Measures

Primary Outcomes (1)

  • decreased complication rate and high patient satisfaction

    October 2016 to June 2025

Interventions

laparoscopic hiatal hernia repairPROCEDURE

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Lecturer

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 22, 2025

Study Start

October 1, 2016

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share