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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Hiatal hernia repair and Nissen fundoplication
Hiatal hernia repair and Dor fundoplication
Kuopio University Hospital
Kuopio, Finland
RECRUITINGAnatomical recurrence of hiatal hernia
Computed tomography based recurrence after Nissen versus Dor fundoplication
Time frame: 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
Time frame: 12 months after the surgery
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates at 12 months
Time frame: 12 months
Reoperation rates
Reoperation rates at 3-, 5-, 10- and 20-years following the surgery
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 12 months
Proton pump inhibitor usage
Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 20 years
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