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Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation
Participants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nissen fundoplication | Active Comparator | Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication |
|
| Dor fundoplication | Experimental | Hiatal hernia repair and Dor (anterior 180-degree) fundoplication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nissen fundoplication | Procedure | Hiatal hernia repair and Nissen fundoplication |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical recurrence of hiatal hernia | Computed tomography based recurrence after Nissen versus Dor fundoplication | 12 months after the surgery |
| Symptomatic recurrence of hiatal hernia | Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence | 12 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic versus asymptomatic recurrence rates | Symptomatic versus asymptomatic recurrence rates at 12 months | 12 months |
| Reoperation rates | Reoperation rates at 3-, 5-, 10- and 20-years following the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ville Palomäki, MD, PhD | Contact | +35817 173 311 | Ville.Palomaki@pshyvinvointialue.fi |
| Name | Affiliation | Role |
|---|---|---|
| Ville Palomäki, MD, PhD | Kuopio University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Recruiting | Kuopio | 70200 | Finland |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Prospective open label randomized trial
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| Dor fundoplication |
| Procedure |
Hiatal hernia repair and Dor fundoplication |
|
| 20 years |
| Managing GERD symptoms with Nissen vs Dor fundoplication | The efficacy of Nissen vs Dor fundoplication techniques in improving the Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (GERD-HRQL) scores at 12 months. Minimum score 0 = no symptoms, maximum score 75 = worst symptoms. | 12 months |
| Dysphagia symptoms after Nissen vs Dor fundoplication | The effect of different fundoplication techniques on dysphagia symptoms assessed by Eating Assessment Tool (EAT-10 ) at 12 months. Score range from 0 to 40 with higher scores indicating more severe dysphagia. | 12 months |
| Hiatal hernia size and recurrence rates | The association between hiatal hernia size and recurrence rates. During surgery, the left-to-right and posterior-to-anterior dimensions of the hiatal opening, as well as whether more than 30% of stomach is herniated , will be recorded. These measurements will then be compared to postoperative recurrence rates." | 12 months |
| Proton pump inhibitor usage | Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery | 20 years |
| The impact of Body Mass Index on recurrence and reoperation rates | The impact of initial Body Mass Index (BMI, kg/m^2) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years) | 20 years |
| The impact of age on recurrence and reoperation rates | The impact of subject age (years) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years) | 20 years |
| The impact of albumin level on recurrence and reoperation rates | The impact of albumin level (g/l) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years) | 20 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |