NCT06935617

Brief Summary

hiatus hernia in frail patient is common and requires suregry

Trial Health

100
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

April 13, 2025

Last Update Submit

April 13, 2025

Conditions

Hiatus Hernia

Outcome Measures

Primary Outcomes (1)

  • recurrence

    three years

Study Arms (1)

hiatus hernia

HH operated by LNF

Procedure: nissein

Interventions

nisseinPROCEDURE

nissein surgery

hiatus hernia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elderly pt with hh

You may qualify if:

  • EP aged ≥60 years for giant sliding HH with

You may not qualify if:

  • 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)

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
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof of general surgery, laparoscopic and GIT surgery

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 20, 2025

Study Start

March 1, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share