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Recruiting Not applicable

Gastropexy in the Repair of Patients with Paraesophageal Hernias

NCT06107634 · tracked via the Priya Life Science Sweden tracker
Sponsor
Ersta Diakoni
Phase
Not applicable
Started
2023-06-01
Last updated
2024-12-18

Condition(s) studied

Paraesophageal Hernia

Investigational drug(s) / intervention(s)

GastropexyParaesophageal hernia repair

Gastropexy: In the intervention group, a three-point gastropexy is added to the repair. First, the right fundus flap is adapted posteriorly to the crural portion of the diaphragm with a 2-3 cm long running non-absorbable suture ("posterior gastropexy"). Second, the left fundus flap is adapted to the diaphragm anterolateral to the hiatus with a 2-3 cm long running non-absorbable suture ("left anterolateral gastropexy"). Finally, the minor curvature of the anterior stomach wall is adapted during reduced intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy").

Paraesophageal hernia repair: Ultrasonic shears are used for dissection. The herniated viscera are completely reduced into the abdomen and the hernia sac in fully dissected and resected. The esophagus is mobilized intraabdominally until at least 3 cm rests below the hiatus without tension. The anterior and posterior vagal nerves are identified and preserved. A posterior crural closure with running non-absorbable sutures is performed. An additional anterior crural closure may be performed at the surgeon's discretion. The fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.

Study summary

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: \- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers Exclusion Criteria: * Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair. * Diagnosis of achalasia or any other significant esophageal motility disorder. * Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent. * Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.

Primary outcome measure(s)

  • Recurrence of hernia at 1 year after surgery — 1 year
    Computer tomography of abdomen and thorax

Trial sites (6)

FacilityCityRegionStatus
Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Skåne University Hospital Lund Lund Sweden Not Yet Recruiting
Nyköping Hospital Nyköping Sweden Recruiting
Ersta Hospital Stockholm Sweden Recruiting
Sundsvall County Hospital Sundsvall Sweden Recruiting
Uppsala Academic Hospital Uppsala Sweden Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06107634 on ClinicalTrials.gov ↗ ← All trials in Sweden