Nissen Versus Dor Hiatal Hernia Repair

Not Applicable

Recruiting

• Conditions: Hiatal Hernia; Paraesophageal Hernia; Recurrence

• Registration Number: NCT06725433
• Lead Sponsor: Kuopio University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-10
• Status Verified: 2025-02
• Study Start: 2025-02-07
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2030-01-30
• Study Completion: 2030-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• At least 18 years of age
• Type II-IV hiatal hernia, confirmed by radiology or endoscopy
• Scheduled for mini-invasive hiatal hernia repair
• Emergency mini-invasive surgery for hiatal hernia
• The informed consent is acquired

Exclusion Criteria

• Recurrent hiatal hernia
• Need for esophageal lengthening procedure (Collis)
• Gangrene or need for any resection during (emergency) surgery
• Need for laparotomy or thoracotomy/thoracoscopy
• No written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anatomical recurrence of hiatal hernia	12 months after the surgery	Computed tomography based recurrence after Nissen versus Dor fundoplication
Symptomatic recurrence of hiatal hernia	12 months after the surgery	Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence

Secondary Outcome Measures

Name	Time	Method
Symptomatic versus asymptomatic recurrence rates	12 months	Symptomatic versus asymptomatic recurrence rates at 12 months
Reoperation rates	20 years	Reoperation rates at 3-, 5-, 10- and 20-years following the surgery
Managing GERD symptoms with Nissen vs Dor fundoplication	12 months	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.
Dysphagia symptoms after Nissen vs Dor fundoplication	12 months	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.
Hiatal hernia size and recurrence rates	12 months	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."
Proton pump inhibitor usage	20 years	Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery
The impact of Body Mass Index on recurrence and reoperation rates	20 years	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)
The impact of age on recurrence and reoperation rates	20 years	The impact of subject age (years) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)
The impact of albumin level on recurrence and reoperation rates	20 years	The impact of albumin level (g/l) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland