Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06107634
NA

Gastropexy in the Repair of Patients with Paraesophageal Hernias

Sponsor: Ersta Diakoni

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2023-06-01

Completion Date

2030-08-02

Last Updated

2024-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

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").

PROCEDURE

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.

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