Gastropexy in the Repair of Patients with Paraesophageal Hernias (PEH3)

Ersta Diakoni

Status: Enrolling

Conditions: Paraesophageal Hernia

Treatments: Procedure: Gastropexy; Procedure: Paraesophageal hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT06107634

Dnr 2023-01956-01

Details and patient eligibility

About

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

Full description

Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.

Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.

Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.

Follow-Up Assessments:

Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.

Patient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:

SF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Standard paraesophageal hernia repair

Active Comparator group

Description:

Standard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication)

Treatment:

Procedure: Paraesophageal hernia repair

Standard paraesophageal hernia repair + gastropexy

Experimental group

Description:

Standard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy)

Treatment:

Procedure: Paraesophageal hernia repair

Procedure: Gastropexy