Clinical trial NCT06107634: Gastropexy in the Repair of Patients with Paraesophageal Hernias
Official title: Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paraesophageal Hernia
Lead sponsor: Ersta Diakoni
Sponsor class: OTHER
Collaborators: name: Göteborg University
name: Sundsvall Hospital
name: Karolinska Institutet
First posted: 2023-10-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conventional paraesophageal hernia repair with the addition of gastropexy
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Recurrence of hernia at 1 year after surgery
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence of hernia at 3 years after surgery
timeFrame: 3 year
measure: Complications after surgery
timeFrame: 30 days after surgery
measure: Length of stay at the hospital after surgery
timeFrame: 30 days after surgery
measure: Changes in the patients perception of quality of life after surgery
timeFrame: 3 months, 12 months, and 36 months
measure: Changes in the patients perception of gastrointestinal symptoms after surgery
timeFrame: 3 months, 12 months, and 36 months
measure: Changes in the patients perception of dysphagia after surgery
timeFrame: 3 months, 12 months, and 36 months
measure: Changes in the patients perception of dysphagia and reflux frequency after surgery
timeFrame: 3 months, 12 months, and 36 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital Lund
city: Nyköping
country: Sweden
facility: Nyköping Hospital
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall County Hospital
city: Uppsala
country: Sweden
facility: Uppsala Academic Hospital
Study officials:
affiliation: Ersta Diakoni
name: Anders Thorell, Professor
role: STUDY_DIRECTOR
References: