Gastropexy in the Repair of Patients with Paraesophageal Hernias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastropexy, Paraesophageal hernia repair.
- Who it may be relevant to
- Registry conditions: Paraesophageal Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial
Overview
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.
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 intra - 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 fund
Primary outcome measures
- Recurrence of hernia at 1 year after surgery [Time frame: 1 year]
Secondary outcome measures (7)
- Recurrence of hernia at 3 years after surgery [Time frame: 3 year]
- Complications after surgery [Time frame: 30 days after surgery]
- Length of stay at the hospital after surgery [Time frame: 30 days after surgery]
- Changes in the patients perception of quality of life after surgery [Time frame: 3 months, 12 months, and 36 months]
- Changes in the patients perception of gastrointestinal symptoms after surgery [Time frame: 3 months, 12 months, and 36 months]
- Changes in the patients perception of dysphagia after surgery [Time frame: 3 months, 12 months, and 36 months]
- Changes in the patients perception of dysphagia and reflux frequency after surgery [Time frame: 3 months, 12 months, and 36 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Sweden · 6 centers
- Sahlgrenska University Hospital — Gothenburg
- Skåne University Hospital Lund — Lund
- Nyköping Hospital — Nyköping
- Ersta Hospital — Stockholm
- Sundsvall County Hospital — Sundsvall
- Uppsala Academic Hospital — Uppsala
Publications
- Dackhammar JB, Tsoposidis A, Wallenius V, Kostic S, Cengiz Y, Linder G, Jeremiasen M, Analatos A, Lundell L, Hakanson B, Thorell A, Hansson MR. Can gastropexy reduce the recurrence rate after paraesophageal hernia repair? A study protocol for a double blind, randomized, multicenter clinical trial. Trials. 2026 Mar 16;27(1):281. doi: 10.1186/s13063-026-09578-7. PMID 41840686
Identifiers
NCT: NCT06107634 · Dnr 2023-01956-01