Clinical trial NCT06725433: Nissen Versus Dor Hiatal Hernia Repair
Official title: NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiatal Hernia
Paraesophageal Hernia
Recurrence
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective open label randomized trial
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Anatomical recurrence of hiatal hernia
timeFrame: 12 months after the surgery
measure: Symptomatic recurrence of hiatal hernia
timeFrame: 12 months after the surgery
Secondary outcomes:
measure: Symptomatic versus asymptomatic recurrence rates
timeFrame: 12 months
measure: Reoperation rates
timeFrame: 20 years
measure: Managing GERD symptoms with Nissen vs Dor fundoplication
timeFrame: 12 months
measure: Dysphagia symptoms after Nissen vs Dor fundoplication
timeFrame: 12 months
measure: Hiatal hernia size and recurrence rates
timeFrame: 12 months
measure: Proton pump inhibitor usage
timeFrame: 20 years
measure: The impact of Body Mass Index on recurrence and reoperation rates
timeFrame: 20 years
measure: The impact of age on recurrence and reoperation rates
timeFrame: 20 years
measure: The impact of albumin level on recurrence and reoperation rates
timeFrame: 20 years
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Ville Palomäki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: