RecruitingNot ApplicableNCT06107634

Gastropexy in the Repair of Patients with Paraesophageal Hernias

Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial


Sponsor

Ersta Diakoni

Enrollment

124 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • \- 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 Criteria4

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREGastropexy

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").

PROCEDUREParaesophageal 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.


Locations(6)

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital Lund

Lund, Sweden

Nyköping Hospital

Nyköping, Sweden

Ersta Hospital

Stockholm, Sweden

Sundsvall County Hospital

Sundsvall, Sweden

Uppsala Academic Hospital

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06107634


Related Trials