Can gastropexy reduce the recurrence rate after paraesophageal hernia repair? A study protocol for a double blind, randomized, multicenter clinical trial.
J Blixt Dackhammar, A Tsoposidis, V Wallenius...
https://pubmed.ncbi.nlm.nih.gov/41840686Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06107634
Can Gastropexy Improve the Efficacy of Crural Repair in Patients with Paraesophageal Hernias? A Double Blind, Randomized, Multicenter Clinical Trial
Led by Ersta Diakoni · Updated on 2024-12-18
124
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
Sponsors
E
Ersta Diakoni
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of adding gastropexy to conventional surgical repair for patients with primary paraesophageal hernias. This randomized, triple-blind clinical trial compares standard crural repair combined with a Nissen fundoplication against the same procedure with an additional three-point gastropexy. The study aims to determine if the gastropexy improves outcomes in hernia repair. Participants are divided into two groups: the control group receives standard paraesophageal hernia repair, which includes crural suturing and a total (Nissen) fundoplication. The interventional group receives the same standard repair plus a gastropexy, which involves fixing parts of the stomach wrap to the diaphragm and abdominal wall using sutures. The study includes preoperative and postoperative imaging with CT scans at baseline, 1 year, and 3 years after surgery to assess anatomical results. Participants will complete several questionnaires before surgery and at 3 months, 1 year, and 3 years post-surgery to assess quality of life, gastrointestinal symptoms, reflux frequency, and swallowing difficulties. Outcomes include hernia recurrence at 1 and 3 years, surgical complications, hospital stay length, and patient-reported symptom changes. The total follow-up period extends to 3 years with regular assessments to monitor safety and efficacy.
CONDITIONS
Brief Title
Gastropexy in the Repair of Patients with Paraesophageal Hernias
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) scheduled for elective or emergency surgical repair at participating centers
You will not qualify if you...
- Previous major upper gastrointestinal surgery, including prior hiatal hernia repair
- Diagnosis of achalasia or any other significant esophageal motility disorder
- Inability to understand the study or provide informed consent
- Severe comorbidities with an ASA physical status score greater than III
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay up to 30 days after surgery
Participants undergo surgery to repair the paraesophageal hernia with either standard crural repair and Nissen fundoplication or the addition of a three-point gastropexy, followed by immediate post-operative care.
Hospital stay with daily assessments until discharge
Post-operative Follow-up
Duration - 3 years
Participants have follow-up assessments including CT scans and completion of questionnaires about quality of life, gastrointestinal symptoms, dysphagia, and reflux frequency to monitor recovery and outcomes after surgery.
CT scans at 1 and 3 years post-surgery; questionnaires at 3 months, 1 year, and 3 years post-surgery
Trial Site Locations
Total: 6 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
2
Skåne University Hospital Lund
Lund, Sweden, 221 85
Not Yet Recruiting
3
Nyköping Hospital
Nyköping, Sweden, 611 85
Actively Recruiting
4
Ersta Hospital
Stockholm, Sweden, 11691
Actively Recruiting
5
Sundsvall County Hospital
Sundsvall, Sweden, 856 43
Actively Recruiting
6
Uppsala Academic Hospital
Uppsala, Sweden, 751 85
Actively Recruiting
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Research Team
M
Marcus Reuterwall Hansson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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