Nissen Versus Dor Hiatal Hernia Repair (NiDor)

Kuopio University Hospital

Status: Enrolling

Conditions: Hiatal Hernia; Paraesophageal Hernia; Recurrence

Treatments: Procedure: Nissen fundoplication; Procedure: Dor fundoplication

Study type: Interventional

Funder types: Other

Identifiers

NCT06725433

KUH5204535

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Nissen fundoplication

Active Comparator group

Description:

Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication

Treatment:

Procedure: Nissen fundoplication

Dor fundoplication

Experimental group

Description:

Hiatal hernia repair and Dor (anterior 180-degree) fundoplication

Treatment:

Procedure: Dor fundoplication