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Not yet recruitingNCT06096402Updated Oct 23, 2023

Gastropexy as a Treatment Option for Paraesophageal Hernia

An observational study in Paraesophageal Hernia, sponsored by University Hospital of North Norway. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by University Hospital of North Norway · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years and older
Sex
All
01

Study summary

The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. The incidence of PEH increases with age and the older patient typically has additional co-morbidities, reduced physiological fitness, and frailty which makes surgery challenging regarding increased morbidity and mortality. Thus, the decision to offer surgery can be challenging in this cohort of patients. The need of an anti-reflux procedure as part of the repair is one of the main subjects for discussion worldwide. To date no consensus exists and many surgical centres do a routine anti-reflux procedure as part of their standard operation for PEH. But is this procedure redundant? Can the patients be managed with a less complicated procedure; an anterior gastropexy with comparable outcome?

Read the detailed description

A hiatal hernia is a widening of the diaphragmatic hiatus causing herniation of the stomach into the thoracic cavity. It develops because of an insufficiency of the hiatus. The paraesophageal hernias (PEH) are classified as grade II-IV hiatal hernia with at least 50 % of the stomach misplaced in the thoracic cavity.

A paraesophageal hernia (PEH) is a potentially dangerous condition. One see in varied degree, the stomach and other organs being misplaced above diaphragm, in the thoracic cavity. Symptoms such as dysphagia, vomitus, weight loss, pain, short breath and emergent situations where abdominal organs are strangulated with risk of tissue death in thorax defines whether a patient should be offered operation and how fast it should be performed.

The operative management of PEH has become a laparoscopic procedure within the last 20-30 years with a concomitant significant decrease in morbidity and length of hospital stay. It is managed by different subspecialized surgeons, all of them having different perspectives and approaches to this condition. Surgery in this area is potentially high-risk operations with risk of perforation of oesophagus, injury to lungs, aorta, pericardia, spleen and stomach. Without operation symptomatic patients with PEH are at risk of developing an acute surgical condition with organ perforation with high per-and postoperative mortality.

Contemporary surgical technique is divided into three crucial steps; 1) removal of the hernia sac, 2) hiatoplasty with or without mesh and 3) an anti-reflux procedure and/or gastropexy. Each step is managed differently among surgeons/centres worldwide with varying evidence. Many surgeons add an anti-reflux procedure to the surgical management of PEH, to protect against postoperative acid reflux. The argument is that an anti-reflux procedure lowers postoperative reflux and recurrence of the paraesophageal hernia, but this is without clear evidence. As an addition or an alternative in step three of the PEH procedure, some centres do an anterior gastropexy to anchor the stomach in the abdominal cavity. It is a simple technique compared with an anti-reflux procedure with possibly equal satisfactory long-term outcomes but less postoperative complications. However, evidence is sparse and larger studies on this technique are highly warranted.

The aim is to study the need of a fundoplication as part of the procedure for PEH regarding symptom control and quality of life. For this reason, The investigator want to set up a prospective two-armed multicenter study in collaboration with St. Olav's Hospital, Trondheim and Gastroenheden, Hvidovre, Denmark. The reason for this collaboration is 1) to enlarge the group of investigation, as PEH is a rare condition, 2) to compare current practice (fundoplication/no fundoplication) among the included institutions. .

02

Conditions studied

  • Paraesophageal Hernia

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Keywords

  • paraesophageal hernia
  • gastropexy
  • fundoplication
03

In context

Hernia, Hiatal

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

This study's planned enrollment of 220 is above the median of 151 across 29 observational studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Adults with a paraesophageal hernia with indication of operation

Inclusion criteria

  • Both emergent and elective repair of the paraoesophageal hernia

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (estimated)
Patient registry
No

Groups and cohorts

  • anterior gastropexy, no fundoplication

    patients with indication of operative management of a paraesophageal hernia

    Procedure: no intervention, but surgical practice as usual is continued. Its a pragmatic study

  • anterior gastropexy and fundoplication

    patients with indication of operative management of a paraesophageal hernia

    Procedure: no intervention, but surgical practice as usual is continued. Its a pragmatic study

Interventions

  • Procedureno intervention, but surgical practice as usual is continued. Its a pragmatic study

    no intervention

06

What researchers measure

Primary outcomes

  1. peri- and postoperative complications

    according to clavien-dindo score

    Time frame: 30 days after operation

  2. Gastro-esophageal reflux disease-Health related quality of life, GERD-HRQL

    The GERD-HRQL questionnaire evaluates heartburn, dysphagia and regurgitation on a scale from zero (no symptoms) to five (severe symptoms) in 15 questions. Maximum score ranges from zero to 75 points

    Time frame: Before surgery and 3,6 and 12 months after surgery

  3. Short From questionnaire (SF-36) Health related quality of life

    SF-36 is a well-established questionnaire consisting of 36 health related questions. Scale is from 0-100 for each section (8 sections) A high score corresponds to a better health status

    Time frame: before surgery and 3, 6 and 12 months after surgery

Secondary outcomes

  1. Total number of patients with radiological recurrence after one year

    esophagus x-ray/barium swallow one year after surgery

    Time frame: one year after surgery

07

Study locations

3 sites
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References and documents

Individual participant data

Plan to share: Undecided

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 Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06096402
Responsible party
Kim Erlend Mortensen (MD, PhD, University Hospital of North Norway) — Principal investigator
First posted
Oct 23, 2023
Start date
Jun 1, 2024 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 23, 2023

Study contacts

Lene Osterballe, MD
Contact
lene.osterballe@unn.no
+4797572401
Kim Erlend Mortensen, MD, PhD
study director · University of North Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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