hiatal hernia
Conditions
Interventions
Experimental group :After closing the hiatal orifice with non-absorbable suture knots, an 8.0*8.0cm mesh was trimmed into a V-shape, flattened, and secured using an absorbable stapler with 5mm staples
Control group:The hiatal orifice was closed using non-absorbable suture knots alone, with no additional mesh reinforcement applied.
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed patients aged 18-80 years; 2.Hiatal hernia confirmed by imaging or endoscopy, with intraoperative measurement showing maximum hernia defect diameter <5cm; 3.Non-recurrent hiatal hernia patients; 4.Patients without concurrent pulmonary, cardiac, or abdominal diseases or surgical history; 5.Patients with cardiopulmonary, hepatic and renal functions sufficient to tolerate surgery; 6.Assessed by study physicians as having no psychological issues; 7.Patients and their families willing to participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with concurrent severe cardiopulmonary diseases, gastrointestinal disorders, or history of thoracic/upper abdominal surgery; 2.Patients requiring emergency surgery for conditions such as obstruction, perforation, or hemorrhage; 3.Patients with preoperative poor esophageal function (e.g., achalasia); 4.Patients who recently underwent other abdominal or thoracic surgeries; 5.ASA classification = Grade IV and/or ECOG performance status score > 2; 6.Patients with severe hepatic/renal insufficiency, cardiopulmonary dysfunction, coagulation disorders, or severe comorbidities rendering them unfit for surgery; 7.History of severe allergies or high risk of foreign body rejection; 8.History of severe mental illness; pregnant or lactating women; or uncontrolled preoperative infections; 9.Other factors deemed by the Investigator as likely to cause forced discontinuation, including: concurrent severe illnesses (including mental illness) requiring combined treatment, alcoholism, substance abuse, familial/social factors, or any conditions potentially affecting Subject safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the hiatal hernia recurrence rate within 3 years postoperatively (including radiographic recurrence and symptomatic recurrence).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative and postoperative complications.;Hospitalization costs;therapeutic antibiotic usage;Reflux Disease Questionnaire (RDQ) ;Gastrointestinal Quality of Life Index (GIQLI);Abdominal CT scan;Esophageal X-ray;Esophageal manometry;24-hour pH measurement; | — |
Countries
China
Contacts
Public ContactXin Li
The First Hospital of China Medical University
Outcome results
None listed